FDA Inspection
Intas Pharmaceuticals LimitedIntas Pharmaceuticals Limited – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Intas Pharmaceuticals Limited, with an inspection on December 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · fbcaf201-b95a-47b1-9d62-b65a4c37d203
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074349
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Intas Pharmaceuticals Limited
14| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 12, 2023 | Not classified | Office of Inspections and Investigations | |
| August 2, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 17, 2018 | Not classified | Office of Inspections and Investigations | |
| June 8, 2018 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Intas Pharmaceuticals Limited
- FDA Inspection 1245599 - 2024-07-12
- FDA Inspection 1206170 - 2023-05-12
- FDA Inspection 1098380 - 2019-08-02
- FDA Inspection 1067525 - 2018-08-17
- FDA Inspection 1056170 - 2018-06-08
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