FDA Inspection
Reckitt Benckiser Healthcare India Private LimitedReckitt Benckiser Healthcare India Private Limited – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Reckitt Benckiser Healthcare India Private Limited, with an inspection on July 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 26, 2019
- Product Type
- Drugs
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ID · 47d31c92-d7f3-4e21-a978-403b371e4a62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097967
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Reckitt Benckiser Healthcare India Private Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Reckitt Benckiser Healthcare India Private Limited
- FDA Inspection 883422 - 2014-06-19
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