FDA Inspection 858623 — Blairex Laboratories, Inc
The FDA completed an inspection of Blairex Laboratories, Inc on Dec 12, 2013 in Columbus, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |