FDA Inspection
Devakam Apothecary Hall Co., Ltd.Devakam Apothecary Hall Co., Ltd. – FDA Inspection, Sep 7, 2017
Record Details
This FDA Inspection record concerns Devakam Apothecary Hall Co., Ltd., with an inspection on September 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 338929e6-5f65-4d39-b942-b7a87bcdc6a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1024295
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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