FDA Inspection
Acella Pharmaceuticals, LLCAcella Pharmaceuticals, LLC – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns Acella Pharmaceuticals, LLC, with an inspection on September 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Acella Pharmaceuticals, LLC
- Inspection Date
- September 17, 2021
- Product Type
- Drugs
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ID · 830bb53d-854f-43a4-9743-9247044c9ca5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152922
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 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 |
| 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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