FDA Inspection
Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC – FDA Inspection, Apr 2, 2010
Record Details
This FDA Inspection record concerns Acella Pharmaceuticals, LLC, with an inspection on April 2, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acella Pharmaceuticals, LLC
- Inspection Date
- April 2, 2010
- Product Type
- Drugs
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ID · 7538350c-cd64-473e-9f7f-37c3a3043f1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656389
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(b)(1)Written complaint record must include
- 21 CFR 211.100(b)SOPs not followed / documented
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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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