FDA Inspection
Aphena Pharma Solutions-Maryland LLCAphena Pharma Solutions-Maryland LLC – FDA Inspection, Jun 27, 2013
Record Details
This FDA Inspection record concerns Aphena Pharma Solutions-Maryland LLC, with an inspection on June 27, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 27, 2013
- Product Type
- Drugs
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ID · 672a33bf-d245-4502-b977-35b3c6cc5130
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837987
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.122(h)Printing devices
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Aphena Pharma Solutions-Maryland LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2026 | VAI | Baltimore District Office | Drug Quality Assurance |
| December 15, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2018 | Not classified | Baltimore District Office | |
| September 10, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 13, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Aphena Pharma Solutions-Maryland LLC
- FDA Inspection 1304024 - 2026-02-20
- FDA Inspection 1158849 - 2021-12-15
- FDA Inspection 1049615 - 2018-04-20
- FDA Inspection 941852 - 2015-09-10
- FDA Inspection 765071 - 2012-01-13
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