FDA Inspection
Abraxis Bioscience, LLCAbraxis Bioscience, LLC – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Abraxis Bioscience, LLC, with an inspection on June 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Abraxis Bioscience, LLC
- Inspection Date
- June 24, 2016
- Product Type
- Drugs
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ID · bdfe78fc-b849-4a70-8f74-4a716d265e0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987449
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Abraxis Bioscience, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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