FDA Inspection
Premier Brands Of America Inc.Premier Brands Of America Inc. – FDA Inspection, May 16, 2022
Record Details
This FDA Inspection record concerns Premier Brands Of America Inc., with an inspection on May 16, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 16, 2022
- Product Type
- Drugs
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ID · 5a2827d2-777b-41c7-90f1-0596866ec20f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1169521
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Premier Brands Of America Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 21, 2011 | OAI | 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 954128 - 2016-01-08
- FDA Inspection 858026 - 2013-11-15
- FDA Inspection 730630 - 2011-06-21
- FDA Inspection 662525 - 2010-05-20
- FDA Inspection 567683 - 2009-02-20
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