FDA Inspection
Sidmak Laboratories India Pvt LtdSidmak Laboratories India Pvt Ltd – FDA Inspection, Sep 6, 2019
Record Details
This FDA Inspection record concerns Sidmak Laboratories India Pvt Ltd, with an inspection on September 6, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ef699078-18db-4b8b-8362-98a457b78214
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102227
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Sidmak Laboratories India Pvt Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sidmak Laboratories India Pvt Ltd
- FDA Inspection 1207996 - 2023-05-13
- FDA Inspection 1123559 - 2020-02-14
- FDA Inspection 1009631 - 2017-03-31
- FDA Inspection 881291 - 2014-06-06
- FDA Inspection 806835 - 2012-10-26
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