FDA Inspection
Intas Pharmaceuticals LimitedIntas Pharmaceuticals Limited – FDA Inspection, May 28, 2019
Record Details
This FDA Inspection record concerns Intas Pharmaceuticals Limited, with an inspection on May 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7ad4efa4-b817-4d06-9a24-f9b779e98f03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092798
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Intas Pharmaceuticals Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 19, 2017 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
| October 19, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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