FDA Inspection
Apotex Pharmachem India Pvt Ltd.Apotex Pharmachem India Pvt Ltd. – FDA Inspection, Jan 31, 2014
Record Details
This FDA Inspection record concerns Apotex Pharmachem India Pvt Ltd., with an inspection on January 31, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 31, 2014
- Product Type
- Drugs
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ID · 3e7007d7-ba54-46c4-890b-2ddf496d6a70
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 868946
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
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 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2016 | VAI | 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 1057873 - 2018-06-26
- FDA Inspection 978926 - 2016-06-03
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