FDA Inspection
AustarPharma, LLCAustarPharma, LLC – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns AustarPharma, LLC, with an inspection on May 23, 2018, issued by the New Jersey District Office, covering human drugs.
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ID · 4648d24c-7e56-4666-af77-cc2fc35305a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052925
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192No written record of investigation
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Other FDA inspections of AustarPharma, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2024 | VAI | New Jersey District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| April 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2019 | Not classified | New Jersey District Office | |
| January 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2017 | Not classified | New Jersey District Office |
Other documents for AustarPharma, LLC
- FDA Inspection 1236866 - 2024-12-04
- FDA Inspection 1201798 - 2023-04-05
- FDA Inspection 1080178 - 2019-02-11
- FDA Inspection 1037881 - 2018-01-05
- FDA Inspection 1015357 - 2017-06-22
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