FDA Inspection 915252 — Product Quest Manufacturing LLC
The FDA completed an inspection of Product Quest Manufacturing LLC on Feb 18, 2015 in Daytona 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
- Feb 18, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Daytona Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |