FDA Inspection
Abraxis Bioscience, LLCAbraxis Bioscience, LLC – FDA Inspection, Oct 6, 2023
Record Details
This FDA Inspection record concerns Abraxis Bioscience, LLC, with an inspection on October 6, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 58116093-0aaf-4761-95a0-a780c7719f06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220002
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Abraxis Bioscience, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 24, 2016 | 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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