FDA Inspection 1261773 — Pillar5 Pharma Inc.
The FDA completed an inspection of Pillar5 Pharma Inc. on February 7, 2025 in Arnprior. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 7, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arnprior (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |