FDA Inspection
Windlas Healthcare Private LimitedWindlas Healthcare Private Limited – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Windlas Healthcare Private Limited, with an inspection on August 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d4858c1b-f893-4957-948e-2fe45f28af48
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1101210
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Windlas Healthcare Private Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2017 | Not classified | Office of Inspections and Investigations | |
| February 17, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Windlas Healthcare Private Limited
- FDA Inspection 1055378 - 2018-06-01
- FDA Inspection 1023197 - 2017-07-21
- FDA Inspection 962641 - 2016-02-17
- FDA Inspection 882841 - 2014-06-13
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