FDA Inspection 874347 — PLZ Corp
The FDA completed an inspection of PLZ Corp on April 24, 2014 in Fall River, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fall River, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |