FDA Inspection 1225549 — Bolger & O'Hearn Inc
The FDA completed an inspection of Bolger & O'Hearn Inc on December 19, 2023 in Fall River, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fall River, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |