FDA Inspection
Premier Brands Of America Inc.Premier Brands Of America Inc. – FDA Inspection, Nov 15, 2013
Record Details
This FDA Inspection record concerns Premier Brands Of America Inc., with an inspection on November 15, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 15, 2013
- Product Type
- Drugs
View Company Profile
ID · 22efa67e-72b6-48d4-87f8-a769c9b1df91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858026
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.125(f)Procedures Written and Followed
Full citation text and observation details available on the Dashboard.
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 |
| 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 1169521 - 2022-05-16
- FDA Inspection 954128 - 2016-01-08
- FDA Inspection 730630 - 2011-06-21
- FDA Inspection 662525 - 2010-05-20
- FDA Inspection 567683 - 2009-02-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.