FDA Inspection 917128 — Pillar5 Pharma Inc.
The FDA completed an inspection of Pillar5 Pharma Inc. on February 6, 2015 in Arnprior. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arnprior (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |