FDA Inspection 1027348 — BPS 60
The FDA completed an inspection of BPS 60 on September 15, 2017 in Montataire. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montataire (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |