FDA Inspection 995264 — Biovem, Inc.
The FDA completed an inspection of Biovem, Inc. on November 30, 2016 in Pompano Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 30, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |