FDA Inspection 858026 — Premier Brands Of America Inc.
The FDA completed an inspection of Premier Brands Of America Inc. on November 15, 2013 in Orangeburg, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orangeburg, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |