FDA Inspection
Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC – FDA Inspection, Mar 22, 2012
Record Details
This FDA Inspection record concerns Acella Pharmaceuticals, LLC, with an inspection on March 22, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acella Pharmaceuticals, LLC
- Inspection Date
- March 22, 2012
- Product Type
- Drugs
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ID · 46d1bea2-3b6a-400e-9343-816871aa4d4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779795
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Acella Pharmaceuticals, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | VAI | Atlanta District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| February 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 7, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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