FDA Inspection 765724 — Biogenesis, Inc
The FDA completed an inspection of Biogenesis, Inc on February 2, 2012 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |