FDA Inspection 1063691 — Capzer Pharmaceuticals
The FDA completed an inspection of Capzer Pharmaceuticals on Aug 29, 2018 in Lake Worth Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lake Worth Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |