FDA Inspection 1165537 — Bryant Ranch PrePack
The FDA completed an inspection of Bryant Ranch PrePack on March 17, 2022 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |