FDA Inspection
Apothecon Pharmaceuticals Private LimitedApothecon Pharmaceuticals Private Limited – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns Apothecon Pharmaceuticals Private Limited, with an inspection on August 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 931b078e-5823-4705-9264-b0ce31b5503e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063149
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.192Quality control unit review of records
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Other FDA inspections of Apothecon Pharmaceuticals Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Office of Inspections and Investigations | |
| July 28, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2023 | VAI | Office of Inspections and Investigations | |
| January 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 17, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Apothecon Pharmaceuticals Private Limited
- FDA Inspection 1320502 - 2026-05-01
- FDA Inspection 1211227 - 2023-07-28
- FDA Inspection 1209402 - 2023-06-16
- FDA Inspection 1198363 - 2023-01-27
- FDA Inspection 1099873 - 2019-07-17
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