FDA Inspection 662525 — Premier Brands Of America Inc.
The FDA completed an inspection of Premier Brands Of America Inc. on May 20, 2010 in Orangeburg, NY. 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
- May 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |