FDA Inspection
Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns Acella Pharmaceuticals, LLC, with an inspection on February 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 91bf22b1-c467-4d2f-9868-9300f0fee498
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197977
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
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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 |
| 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 |
| September 10, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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