FDA Inspection
PediFix, Inc.PediFix, Inc. – FDA Inspection, Feb 12, 2024
Record Details
This FDA Inspection record concerns PediFix, Inc., with an inspection on February 12, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e6310589-5518-4a87-a643-04816e892eea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229332
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
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Other FDA inspections of PediFix, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 7, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PediFix, Inc.
- FDA Inspection 945810 - 2015-10-13
- FDA Inspection 753558 - 2011-11-15
- FDA Inspection 655612 - 2010-04-07
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