FDA483表：美国Reed药房

罗伊鲱

转自：GMP信息共享

受检公司：Reed Pharmacy, Inc.
公司地址：118 South Broadway, Sterling, KS 67579
厂商类型：Producer of Nonsterile Drugs
检查员：Robert J Ham, Investigator
检查日期：2018.09.24-27
发布日期：2018.11.21

This document lists observations made bythe FDA representative(s) during the inspection of your facility. They areinspectional observations, and do not represent a final Agency determinationregarding your compliance. If you have an objection regarding an observation,or have implemented, or plan to implement, corrective action in response to anobservation, you may discuss the objection or action with the FDArepresentative(s) during the inspection or submit this information to FDA atthe address above. If you have any questions, please contact FDA at the phonenumber and address above.
本文件列出了FDA代表在对你工厂检查期间所发现的问题。这些只是检查发现，并不代表FDA对你公司合规性的最终结论。如你们对某一缺陷有异议，或已实施或计划实施纠正措施来纠正某个缺陷，你们在检查期间与FDA代表讨论你们的异议与措施，或通过上述地址向FDA提交资料。如有问题，请通过上述地址电话与FDA取得联系。

OBSERVATION1 缺陷1

Drug products do not bear an expirationdate determined by appropriate stability data to assure they meet applicableidentify, strength, quality, and purity at the time of use.
药品不具有由适当的稳定性数据确定的有效期，以确保它们在使用时符合适当的鉴别，含量，质量和纯度。

Specifically, 具体的

You have not performed stability studies and consequently do nothave data to support the expiration date assigned to your finished drug productLET (Lidocaine, Epinephrine, Tetracaine) topical solution. You stated thecustomer may store it refrigerated for 6-months. You have produced LET topical solutionfour times since 02/20I7. LET topical solution is indicated for anesthesia of lacerations,to include children.
你们尚未进行稳定性研究，因此没有数据支持指定的成品药物LET（利多卡因，肾上腺素，丁卡因）外用溶液的有效期。你们说客户可以冷藏6个月。自2017年02月起，您已经生产了四次LET外用溶液。 LET外用溶液适用于撕裂伤的麻醉，包括儿童。

OBSERVATION2  缺陷2

Your firm released drug product in which the strength differs from, or itspurity or quality falls below, that which it purports or isrepresented to possess.
贵公司放行的药品含量不同，或其纯度或质量低于其声称或表示含有的药物成分。

Specifically, 具体的

You incorporate food grade Sodium Metabisulfite, lot #  （b）（4）into yourfinished drug product LET (Lidocaine, Epinephrine, Tetracaine) topical solution. TheSodium Metabisulfite does not have an expirationdate and you can not determine how long you have used it. You do not havescientifically justified data to support this product meets release orstability requirements.
你们将食品级焦亚硫酸氢钠，＃（b）（4）批次加入到您的成品药物LET（利多卡因，肾上腺素，丁卡因）外用溶液中。焦亚硫酸氢钠没有有效期，你们无法确定使用了多长时间。 你们没有科学合理的数据来支持此产品满足放行或稳定性要求。

OBSERVATION3  缺陷3

Testing and release of drug products fordistribution do not include appropriate laboratory determination of satisfactoryconformance to the final specifications and identity and strength of eachactive ingredient prior to release.
用于销售的药品的检测和放行，没有包括在放行之前对每种活性成分的最终规格和特性以及含量的令人满意的与标准一致的适当实验室测定。

Specifically, 具体的

You do not test any of your drug products quality, strength orpurity before they are released. You have produced and distributed thefollowing products: LET (Lidocaine, Epinephrine, Tetracaine) topical solution;Eucerin / TMC 0.1% Cream 1:1(Triamcinolone, Eucerin); Canker Sore Rinse (Nystatin, Prednisone,Diphenhydramine, Tetracycline) and others since 07/2018.
在放行之前，你们不会检测任何药品的质量，含量或纯度。 你们生产并销售以下产品：LET（利多卡因，肾上腺素，丁卡因）外用溶液; 优色林/ TMC 0.1％乳膏1：1（曲安西龙，优色林）; 自2018年7月起，口腔溃疡冲洗液（制霉菌素，泼尼松，苯海拉明，四环素）等。

OBSERVATION4  缺陷4

Equipment and utensils are not cleaned andsanitized at appropriate intervals to prevent contamination that would alterthe safety, identity, strength, quality or purity of the drug product.
设备和器具没有在适当的时间间隔进行清洁和消毒，以防止污染，从而改变药品的安全性，特性，含量，质量或纯度。

Specifically, 具体的

You clean your product contact compounding surfaces with botanicalcleaner and/ or soap and water. You do not have scientific justificationensuring these direct product contact surfaces are free from contaminationprior to use. Products made utilizing these surfaces include but are notlimited to Eucerin I TMC 0.1% Cream 1:1 (Triamcinolone, Eucerin); Triple NippleOintment (Nystatin, Betamethasone, Mupirocin); etc.
使用植物清洁剂和/或肥皂和水清洁产品接触混合表面。你们没有科学依据确保这些直接的产品接触表面在使用前没有污染。 利用这些表面制成的产品包括但不限于优色林/ TMC 0.1％乳膏1：1（曲安西龙，优色林）; 三重乳头软膏（制霉菌素，倍他米松，莫匹罗星）; 等等。

OBSERVATION5  缺陷5

The batch production and control recordsare deficient in that they do not include documentation of the accomplishmentof each significant step in manufacturing.
批生产和控制记录的不足之处在于它们不包括在生产过程中每个重要步骤的完成的文件。

Specifically, 具体的

You do not have production records which require elements such asthe order of introduction of each component, descriptions of containers andclosures used, weighing of components, in-process steps or inspections of yourproduct(s). Products made without records include but are not limited to LET (Lidocaine,Epinephrine, Tetracaine) topical solution.
你们没有生产记录，这些记录需要诸如每个组件的引入顺序，所用容器和封盖的描述，组件称重，过程中步骤或产品检查等部分。没有记录的产品包括但不限于LET（利多卡因，肾上腺素，丁卡因）外用溶液。

hack

很好，谢谢分享

fruutuun

这企业做得好差

小金库

谢谢分享！！！