FDA Inspection 1226692 — Pillar5 Pharma Inc.
The FDA completed an inspection of Pillar5 Pharma Inc. on December 15, 2023 in Arnprior. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 15, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arnprior (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 4576 | 21 CFR 211.192 | No written record of investigation |