FDA Inspection 1034239 — Delpharm Montreal Inc.
The FDA completed an inspection of Delpharm Montreal Inc. on December 8, 2017 in Pointe-Claire. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 8, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pointe-Claire (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |