FDA Inspection
Premier Brands Of America Inc.Premier Brands Of America Inc. – FDA Inspection, May 20, 2010
Record Details
This FDA Inspection record concerns Premier Brands Of America Inc., with an inspection on May 20, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 20, 2010
- Product Type
- Drugs
View Company Profile
ID · 69d705be-926d-41fb-b602-0bc98f5dbbf5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662525
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Approval and review of procedures
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 |
| 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 |
| 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 730630 - 2011-06-21
- 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.