FDA Inspection
Sidmak Laboratories India Pvt LtdSidmak Laboratories India Pvt Ltd – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Sidmak Laboratories India Pvt Ltd, with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0d4b4d0f-3ce8-4ddd-b51f-3a68e7ad18ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009631
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.160(b)(1)Sampling and testing procedures described
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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 |
| September 6, 2019 | OAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| 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 1102227 - 2019-09-06
- FDA Inspection 881291 - 2014-06-06
- FDA Inspection 806835 - 2012-10-26
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