FDA Inspection
Umedica Laboratories Pvt. Ltd.Umedica Laboratories Pvt. Ltd. – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Umedica Laboratories Pvt. Ltd., with an inspection on May 19, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 62c9f5af-3aca-4b6b-ae53-d15ae36cd752
Inspection Facts
- Inspection number
- 1017664
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
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Other FDA inspections of Umedica Laboratories Pvt. Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 9, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Umedica Laboratories Pvt. Ltd.
- FDA Inspection 1234389 - 2024-03-29
- FDA Inspection 1099875 - 2019-07-05
- FDA Inspection 1038461 - 2018-01-19
- FDA Inspection 953634 - 2015-10-09
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