FDA Inspection 771047 — PLZ Corp.
The FDA completed an inspection of PLZ Corp. on March 8, 2012 in Mississauga. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |