FDA Inspection 1218206 — Pine Pharmaceuticals, LLC
The FDA completed an inspection of Pine Pharmaceuticals, LLC on September 19, 2023 in Tonawanda, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 22749 | FDCA 501(a)(2)(A) | Production areas, difficult to clean/particle generating |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |