FDA Inspection 730630 — Premier Brands Of America Inc.
The FDA completed an inspection of Premier Brands Of America Inc. on June 21, 2011 in Orangeburg, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |