FDA Inspection
Biovem, Inc.Biovem, Inc. – FDA Inspection, Nov 30, 2016
Record Details
This FDA Inspection record concerns Biovem, Inc., with an inspection on November 30, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a88dd551-f764-4c57-9329-3ae997e0e121
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 995264
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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