FDA Inspection 1092200 — PLZ Corp.
The FDA completed an inspection of PLZ Corp. on June 7, 2019 in Mississauga. 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
- June 7, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |