FDA Inspection 1085270 — PLZ Corp
The FDA completed an inspection of PLZ Corp on April 3, 2019 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fall River, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4576 | 21 CFR 211.192 | No written record of investigation |