校准、批记录以及培训不符合cGMP要求，FDA发出警告信。
WARNING LETTER
Premier Trends LLC
MARCS-CMS 621313 — MARCH 14, 2022
March 14, 2022
Dear Ms. Baig:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Premier Trends LLC, FEI 3014373428, at 4 Elisa Dr, Monroe Township, NJ 08831-3527, from September 23, 2021, to September 29, 2021.
美国食品和药物管理局(FDA)于2021年9月23日至2021年9月29日检查了贵司位于Premier Trends LLC, FEI 3014373428, at 4 Elisa Dr, Monroe Township, NJ 08831-3527的药品生产工厂。
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
本警告信总结了制剂成品药违反现行良好生产规范(CGMP)规定的情况。参见《联邦法规法典》第21篇，第210和211部分(21 CFR第210和211部分)。
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
由于生产、加工、包装或贮存方法、设施或控制不符合CGMP，贵司的药品根据《联邦食品、药品和化妆品法案》(FD&C法案)第501(a)(2)(B)条21 U.S.C. 351(a)(2)(B)属于掺假。
Your drug product is misbranded under Section 502(o) of the FD&C Act, 21 U.S.C. 352(o) because your firm is not currently registered as required under section 510(i)(1) of the FD&C Act, 21 U.S.C. § 360(i)(1). In addition, on November 30, 2020, your firm discontinued the drug listing submission for Magic Heal (NDC 72168-786-12) and it has not been relisted.
贵司的药品在FD&C法案第502(o)条21 U.S.C. 352(o)项下贴错了商标，因为贵公司目前没有按照FD&C法案第510(i)(1)条21 U.S.C.§360(i)(1)项的要求进行注册。此外，在2020年11月30日，贵公司停止提交Magic Heal (NDC 72168-786-12)药物上市申请，也没有重新上市。
We reviewed your October 9, 2021, response to our Form FDA 483 in detail. Your product is labeled for intended uses, such as “MAGIC HEAL™ is a blend of unique imported essential oils, such as Neem and Karanja that have been known for centuries for their skin protection and soothing properties,” and “MAGIC HEAL’S soothing aroma…and is absorbed deep into the skin to nourish the rough and cracked skin into smooth and soft skin after only a few applications.” Thus, Magic Heal is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a skin protectant. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with drug CGMP regulations.
我们详细审查了贵司2021年10月9日对我们FDA 483表格的回复。贵司的产品有特定用途的标签，例如“MAGIC HEAL™是一种独特的进口精油的混合物，如楝树和卡兰加，这些精油在几个世纪以来一直以保护和舒缓皮肤的特性而闻名，”和“MAGIC HEAL的舒缓香气……并被皮肤深层吸收，在使用几次后，滋养粗糙和皲裂的皮肤，使其变得光滑和柔软。”因此，Magic Heal是一种“药物”，根据FD&C法案201(g)(1)(B)， 21 U.S.C. 321(g)(1)(B)，因为它旨在用于疾病的诊断、治愈、缓解、治疗或预防，和/或根据FD&C法案201(g)(1)(C)， 21 U.S.C. 321(g)(1)(C)，因为它旨在影响身体的结构或任何功能。具体来说，本产品是用作皮肤保护的。贵司的回复是不充分的，因为没有提供足够的细节或证据来证明的贵司操作符合药品CGMP法规。
During our inspection, our investigators observed specific violations including, but not limited to, the following.
在我们的检查过程中，我们的调查人员发现了具体的违规行为，包括但不限于以下几点。
CGMP Violations
CGMP违规
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
1.每批药品放行前，未能进行适当的实验室检验，以判定与药品最终质量标准（包括每一活性成份的成分、规格）的完全符合性(21 CFR 211.165(a))。
Your firm failed to test your over-the-counter (OTC) drug product, Magic Heal, for the identity and strength of each active ingredient prior to release for distribution. In addition, your firm lacked approved specifications for Magic Heal. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug product, you do not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.
贵公司未能在上市前检测企业的非处方药Magic Heal的每种活性成份的成分和规格。此外，贵公司缺乏放行Magic Heal的程序。检测对于确保贵司生产的药品符合所有预定的适合其预期用途的质量属性至关重要。由于缺乏对每批药品的充分检测，不知道它们是否符合所有适当的成品标准，是否适合放行销售给消费者。
In response to this letter provide:
回复本函请提供：
• a comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
•一份对实验室做法，程序，方法，设备，文件记录和分析员能力进行的综合独立评估。基于此审查，请提供一份详细的计划以整改实验室系统并评估系统有效性。
• a plan to ensure that products in the market are in compliance with appropriate specifications.
•一份确保市场上的产品符合适当标准的计划。
• a list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making lot disposition decision, and the associated written procedures.
•一份化学和微生物质量标准清单，包括用于在批处理决定之前分析每批药品的检验方法以及相关的书面程序。
2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
2. 未能检验每一原辅料样品的成分并确定是否符合纯度、规格和质量的所有适当书面质量标准。也未能定期验证并建立对原辅料供应商检验分析的信任关系。(21 CFR 211.84(d)(1) 和 (2))
Your firm failed to test dimethicone active pharmaceutical ingredients (API) and other components, including neem oil, karanja oil, and lavender, prior to use in the manufacture of your drug product, Magic Heal. You also lacked approved specifications to assure API and other components conform with appropriate specifications for identity, strength, quality, and purity. Though you receive raw materials with a certificate of analysis from your suppliers, you have not performed appropriate incoming analysis of component lots upon receipt, including confirming the identity prior to use in production of your finished drug product. You also relied on your supplier's certificate of analysis without establishing the reliability of your component supplier's test analyses at appropriate intervals.
贵公司在生产药品Magic Heal之前，没有检验二甲基硅氧烷活性药物成分(API)和其他成分，包括neem oil, karanja oil, and lavender。还缺乏批准的规程来确保原料药和其他成分符合适当的鉴别、规格、质量和纯度标准。虽然从供应商那里收到了原料和分析证书，但贵司在收到原料时没有进行适当的进厂成分批次分析，包括在生产成品之前确认其成分。贵司还依赖于供应商的分析证书，而没有在适当时间间隔内确认供应商检验分析的可靠性。
In response to this letter, provide:
针对本函，请提供：
• a comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
•一份针对物料系统的综合独立审查，以确定原辅料、容器和密封件的所有供应商是否都经过充分确认并且这些物料是否指定了合适的有效期或复验期。 审查还应确定入场物料的控制措施是否足以防止使用不合适的容器、密封件和原辅料。
• the chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
•生产用到的原辅料的每一入场批次检验和放行所用的化学和微生物质量控制标准。
• a description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier's certificates of analysis instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier's results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
•一份关于将如何检验每一原辅料批次是否符合所有适用的鉴别、规格、质量和纯度质量标准的描述。如果企业打算接受供应商分析报告单（COA）上的所有检验结果，用以代替每一原辅料的规格、质量和纯度检验，请具体说明将如何通过初始验证以及定期再验证确定供应商检验结果的可靠性。此外，请承诺总是会对每一入场原辅料批次进行至少一项专属鉴别检验。
3. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
3.未能按照为药品生产、加工、包装或贮存所用自动、机械或电子设备或其他类型设备（包括计算机化系统）制订的书面计划对其进行例行校准、检查或核对，以保证此类设备工作性能良好，并做好校准、核对和检查的书面记录并保存。(21 CFR 211.68(a))
You used (b)(4) to manufacture your drug product, Magic Heal. You did not calibrate or verify the accuracy of the temperature-controlled function of the (b)(4) to ensure the manufacturing process is controlled for each batch. In addition, you failed to calibrate or qualify the scale you used to weigh drug components.
贵司使用xx来生产药品Magic Heal。没有校准或验证xx温控功能的准确性，以确保每个批次的生产工艺得到控制。另外，贵司用来称量药物的秤没有经过校准。
In response to this letter, provide an evaluation of all your manufacturing equipment to ensure they are suitable for the intended use. Additionally, provide your corrective action and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of equipment. This plan should ensure, among other things, prompt detection of equipment performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment, and improved systems for ongoing management review.
在回复本函时，请提供对贵司所有生产设备的评估，以确保它们适合预期用途。另外，提供贵司的纠正措施和预防措施(CAPA)计划，以实施对设备的日常、警惕的操作管理监督。除其他事项外，该计划应确保及时发现设备性能问题，有效执行维修，遵守适当的预防性维护时间表，及时对设备进行技术升级，并改进持续管理审查的系统。
4. Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.186(a) and 211.188).
4、未能建立并遵守充分的书面规程来准备主生产与控制主记录，以确保批次间的一致性。未能为生产的每批药品准备批生产与控制记录，并应包括与每批生产和控制有关的完整信息。
You did not prepare adequate master and batch production records for your drug product, Magic Heal. Your batch records lacked:
没有为贵司的药品Magic Heal准备足够的主生产记录和批生产记录。批记录缺少:
• Approval signatures in conformance to a master batch record
•符合主批次记录的批准签名
• Detailed manufacturing instructions
•详细的生产说明
• Identity of equipment used
•所用设备的标识
• Sampling information
•取样信息
• Yield
•产量
In addition, you made several changes to your manufacturing process without justification or change control. For example, you changed the amounts of dimethicone API and other drug components (e.g., neem oil, karanja oil, and lavender) added during manufacturing operations.
另外，企业在没有说明原因或变更控制的情况下对生产工艺进行了多次更改，例如，改变了生产过程中添加的二甲基硅氧烷原料药和其他药物成分(如楝油、卡兰贾油和薰衣草)的数量。
Without adequate batch records, you cannot assure the uniformity of your drug products from batch to batch.
如果没有足够的批记录，就不能保证药品批次间的一致性。
In response to this letter provide:
针对本函，请提供：
• a risk assessment of products released to the U.S. market without adequate and approved production and control documentation.
•在没有足够且经批准的生产和控制文件的情况下，对销售到美国市场的产品进行风险评估。
• procedures you have implemented or revised to assure production records are completed as required and reviewed by your quality unit prior to release of products for distribution.
•企业实施或修订的程序，以确保生产记录按要求完成，并在产品放行销售前由质量部门审核。
• your updated master batch record for Magic Heal.
•Magic Heal的修订主批次记录。
5. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).
5、未能保证从事药品生产、加工、包装或贮存的每位员工均受过教育、培训并有实践经验，或其组合，能够履行委派的职责。(21 CFR 211.25(a))
You failed to ensure that all personnel are qualified for the CGMP operations they perform. For example, your co-owner stated that he is the sole proprietor of the Magic Heal formulation, had full knowledge of the process, and performed all manufacturing operations. However, you lack evidence that your co-owner has the adequate experience to perform these functions nor has received the appropriate CGMP training.
你们未能确保所有人员都具备执行CGMP操作的资格。例如，企业的共同所有人声称是Magic Heal配方的唯一所有人，对工艺有充分的了解，并执行所有的生产操作。然而，企业缺乏证据证明共同所有人有足够的经验执行这些职能，也没有接受过适当的CGMP培训。
Training is essential to ensure proper performance of job functions.
培训对于确保工作职能的正确履行是至关重要的。
In response to this letter provide:
针对本函，请提供：
• a training plan to ensure that:
•一份培训计划，以确保：
o job functions and training needs are established and reviewed on an ongoing basis to monitor whether staff competencies are robust.
o持续审查岗位职能和培训需求，以监控员工能力是否稳定。
o management responsibilities and oversight are defined.
o 明确了管理职责和监督。
o training is conducted with sufficient frequency to assure employees maintain understanding of all applicable CGMP requirements.
o培训频率足够，以保证员工持续理解所有适用的CGMP要求。
o all staff who conduct or supervise CGMP functions are properly trained in CGMP, so that your operations are performed in a manner that assures drug safety, identity, strength, quality, and purity.
o所有执行或监督CGMP职能的员工均适当接受CGMP培训，以便以确保药品安全，鉴别，规格，质量和纯度的方式运作。
o qualified individuals perform training.
o由有资质的个人提供培训。
o provisions are implemented for evaluating staff comprehension, training effectiveness, and ensuring appropriate modifications where needed.
o实施规定以评估员工的理解程度，培训的有效性以及确保在必要时进行适当的改进。
• an assessment of the impact of the lack of appropriate training on marketed drug products.
•一份因缺乏适当培训对市售药品影响的评估。
6. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
6、未设置完善的质量管理部门，并具有批准和拒绝所有原辅料、药品容器、密封件、中间体、包装材料、标签及药品的职责与权力。 (21 CFR 211.22(a))
Your firm lacks a quality unit (QU) and approved written procedures defining QU responsibilities and controls. In addition, your firm failed to establish adequate written responsibilities and procedures for:
贵公司缺乏质量部门（QU）和经批准的书面程序来定义QU的责任和控制。此外，贵公司未能就以下事项建立充分的书面职责和程序：
• Batch release
•批次放行
• Manufacturing processes
•生产过程
• Laboratory deviations and CAPAs
•实验室偏差纠正预防措施
• Complaints
•投诉
• Recalls
•召回
• Handling of drug product returns and rejects
•药品退货和拒收的处理
In response to this letter, provide a comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
针对本函，请提供一份综合评估及整改计划，以确保赋予了QU足够的权限和资源来有效地履行其职能。评估应包括但不限于：
• a determination of whether procedures used by your firm are robust and appropriate.
•确定所用的规程是否稳健且适用；
• provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
• 规定QU在整个操作过程进行监督以评估对适当实践的遵守情况
• a complete and final review of each batch and its related information before the QU disposition decision.
• 在QU处置决定之前对每批次及其相关信息的完整和最终审核
• oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of your product.
• 监督和批准调查以及履行所有其他QU职责，以确保所有产品的鉴别，规格，质量和纯度。
Quality System
质量体系
Your firm’s quality system is inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.
贵公司的质量体系不完善。参见FDA的指导文件《药品CGMP法规的质量体系方法》，帮助实施质量体系和风险管理方法，以满足CGMP法规21 CFR, 210和211部分的要求，网址是https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations。
Repeat Violations at Facility
企业重复违规
In a previous inspection, dated June 28, 2019, FDA cited similar CGMP observations. These findings were also communicated to you during a regulatory meeting on December 17, 2019.
在之前的一次日期为2019年6月28日的检查中，FDA引用了类似的CGMP观察结果。在2019年12月17日的监管会议上，我们也向贵司通报了这些发现。
However, your product continues to be marketed with intended uses that renders your product a drug, and the corrective actions that you have taken in response to the December 17, 2019, regulatory meeting remain inadequate.
然而，产品在市场上的预期用途使贵司的产品成为药物，贵司针对2019年12月17日监管会议采取的纠正措施仍然不足。
Additionally, you did not propose specific remedial actions in your response to our current inspectional findings nor did you indicate whether you intend to comply with drug CGMP regulations. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.
另外，贵司在对我们当前检查结果的回复中没有提出具体的补救措施，也没有表明是否打算遵守药品CGMP法规。屡次失败表明，行政管理层对药品生产的监督和控制是不够的。
CGMP Consultant Recommended
推荐CGMP顾问
Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting drug CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
基于我们在贵公司发现的违规行为的性质，并且由于贵司未能纠正重复的违规行为，我们强烈建议聘请符合21 CFR 211.34所述资格的顾问来帮助贵公司满足药品CGMP要求。使用顾问并不能解除贵公司遵守CGMP的义务。贵公司的执行管理层仍有责任解决包括系统性缺陷在内党的所有缺陷，以确保持续的CGMP符合性。
Misbranding and Registration/Listing Violations
错标和注册/上市违规
Based upon the information obtained from the September 29, 2021 inspection, Premier Trends LLC (FEI 3014373428) has been identified as a drug manufacturer for Magic Heal (NDC 72168-786-12). Under section 510(i)(1) of the FD&C Act (21 U.S.C. 360(i)(1)), Premier Trends LLC is required to submit registration information annually by electronic means for each establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is in commercial distribution in the United States. Premier Trends LLC has not fulfilled its registration requirement. As a result, all drugs manufactured in this establishment are misbranded under Section 502(o) of the FD&C Act [21 U.S.C. 352(o)].
根据2021年9月29日检查获得的信息，Premier Trends LLC (FEI 3014373428)已被确定为Magic Heal (NDC 72167 -786-12)的药品生产商。根据《FD&C法案》(21 U.S.C. 360(i)(1))第510(i)(1)条，Premier Trends LLC被要求每年通过电子方式提交其拥有或经营的每个机构的注册信息，这些机构从事在美国商业分销的药物的生产、制备、传播、合成或加工。Premier Trends LLC没有满足其注册要求。因此，根据FD&C法案(21 U.S.C. 352(o))第502(o)条，在该工厂生产的所有药品都是贴错商标的。
In addition, the drug listing submission for Magic Heal (NDC 72168-786-12) under the name and labeler code for Premier Trends LLC (FEI 3014373428) was discontinued on November 30, 2020 and has not been recertified. This date in drug listing, refers to the expiry date of the last lot manufactured. However, Premier Trends LLC continued manufacturing Magic Heal (NDC 72168-786-12) until at least September 29, 2021, when it was inspected. Under section 510 of the FD&C Act as amended and 21 CFR (21 U.S.C. 360(j)(1), 21 CFR 207.17 and 207.41), all drugs manufactured, prepared, propagated, compounded, or processed for U.S. commercial distribution must be listed with FDA. Failure to properly list drug products is prohibited and will render the drugs misbranded (21 U.S.C. 331(p) and 352(o).
此外，Magic Heal (NDC 72168-786-12)在Premier Trends LLC (FEI 3014373428)名称和标签代码下的药物上市申请已于2020年11月30日停止，并没有得到重新认证。药品清单中的这个日期，是指最后一批生产的有效期。然而，Premier Trends LLC继续生产Magic Heal (NDC 72168-786-12)，直到2021年9月29日进行检查。根据修订的FD&C法案第510条和21 CFR (21 U.S.C. 360(j)(1)， 21 CFR 207.17和207.41)，所有用于美国商业分销的生产、制备、传播、合成或加工的药物必须列入FDA。未能正确列出药品是被禁止的，并将导致药品贴错标签(21 U.S.C. 331(p)和352(o))。
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
根据《FD&C法案》(21 U.S.C. 331(a))第301(a)条的规定，禁止在州际贸易中引入或交付错标药品。
Drug Production Cessation
停止药品生产
If you discontinue manufacturing your OTC drug product, Magic Heal, or update your labels please inform us in writing. If you continue manufacturing this product, inform us how you will meet CGMP requirements.
如果企业停止生产OTC药品Magic Heal，或者更新标签，请书面通知我们。如果继续生产该产品，请告知我们将如何满足CGMP要求。
Conclusion
结论
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
在这封信中引用的违规行为并不是企业设施中存在的所有违规行为的清单。企业有责任调查和确定任何违规行为的原因，并防止其再次发生或其他违规行为的发生。
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
请及时纠正违规行为。未能及时并充分地解决该问题可能会导致无需另行通知的监管或法律行动，包括但不限于扣押和禁令。未解决的违规行为也可能妨碍其他联邦机构授予合同。
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
未能解决违规问题还可能导致FDA扣留签发出口证书。FDA可能会拒绝批准将贵公司列为药品生产商的新申请或补充申请，直到任何违规行为被完全解决，并且我们确认贵司符合CGMP。我们可能会重新检查，以核实是否完成了针对任何违规行为的纠正措施。
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
这封信告知了我们的发现，并为贵司提供解决上述缺陷的机会。收到此信后，请在15个工作日内书面回复本办公室。说明已经采取何种措施来解决任何违规，并防止其再次发生。在回复这封信时，可以提供额外的信息供我们考虑，我们将继续评估贵司的活动和操作。如果不能在15个工作日内完成纠正措施，说明延迟的原因和完成计划。
Send your electronic reply to ORAPHARM1_RESPONSES@fda.hhs.gov. Your written notification should refer to Warning Letter #621313 and include FEI number 3014373428.
If you have questions regarding the content of this letter, please contact us through ORAPHARM1_RESPONSES@fda.hhs.gov, and “cc” Compliance Officer Nancy Scheraga (Nancy.Scheraga@fda.hhs.gov).
Sincerely,
/S/
Craig Swanson
Acting Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District
