FDA Inspection
Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC – FDA Inspection, Oct 31, 2013
Record Details
This FDA Inspection record concerns Acella Pharmaceuticals, LLC, with an inspection on October 31, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acella Pharmaceuticals, LLC
- Inspection Date
- October 31, 2013
- Product Type
- Drugs
View Company Profile
ID · 4ee2e852-d63b-46c9-b13e-b97619c15d7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854221
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
8- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.180(f)Responsible firm officials notified in writing
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192Written record of investigation incomplete
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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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