FDA Inspection 1217938 — Fareva Richmond, Inc.
The FDA completed an inspection of Fareva Richmond, Inc. on September 18, 2023 in Henrico, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Henrico, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |