FDA Inspection
Panacea Biotec Pharma LimitedPanacea Biotec Pharma Limited – FDA Inspection, Aug 9, 2019
Record Details
This FDA Inspection record concerns Panacea Biotec Pharma Limited, with an inspection on August 9, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ad642eb0-0926-49b0-b620-9bff618581b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099402
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Panacea Biotec Pharma Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Panacea Biotec Pharma Limited
- FDA Inspection 1220156 - 2023-10-12
- FDA Inspection 1172929 - 2022-06-08
- FDA Inspection 1093361 - 2019-04-30
- FDA Inspection 1035804 - 2017-12-13
- FDA Inspection 954394 - 2015-12-11
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