FDA Inspection
Apotex Pharmachem India Pvt Ltd.Apotex Pharmachem India Pvt Ltd. – FDA Inspection, Jun 26, 2018
Record Details
This FDA Inspection record concerns Apotex Pharmachem India Pvt Ltd., with an inspection on June 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 83e11f47-ad33-4b30-b1b5-6db0305b2caa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057873
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Apotex Pharmachem India Pvt Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2025 | Not classified | Office of Inspections and Investigations | |
| September 2, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 31, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 31, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotex Pharmachem India Pvt Ltd.
- FDA Inspection 1263710 - 2025-03-14
- FDA Inspection 1180313 - 2022-09-02
- FDA Inspection 1118806 - 2020-01-31
- FDA Inspection 978926 - 2016-06-03
- FDA Inspection 868946 - 2014-01-31
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