FDA Inspection
Premier Brands Of America Inc.Premier Brands Of America Inc. – FDA Inspection, Jun 21, 2011
Record Details
This FDA Inspection record concerns Premier Brands Of America Inc., with an inspection on June 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 21, 2011
- Product Type
- Drugs
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ID · eb9f1c0e-0bdd-4790-b8f1-e34fd8ba14fc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 730630
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.122(e)Destruction of obsolete labeling
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.184(e)Records of disposition of rejected material
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
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Other FDA inspections of Premier Brands Of America Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 8, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Premier Brands Of America Inc.
- FDA Inspection 1169521 - 2022-05-16
- FDA Inspection 954128 - 2016-01-08
- FDA Inspection 858026 - 2013-11-15
- FDA Inspection 662525 - 2010-05-20
- FDA Inspection 567683 - 2009-02-20
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