FDA Inspection
Renu Laboratories, Inc.Renu Laboratories, Inc. – FDA Inspection, Dec 28, 2011
Record Details
This FDA Inspection record concerns Renu Laboratories, Inc., with an inspection on December 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Renu Laboratories, Inc.
- Inspection Date
- December 28, 2011
- Product Type
- Drugs
View Company Profile
ID · 4dca8d0f-7cfd-4fe7-8134-5a7310ace968
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 760599
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 13 citations.
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Other FDA inspections of Renu Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| July 27, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Renu Laboratories, Inc.
- FDA Inspection 1254082 - 2024-09-30
- FDA Inspection 1175495 - 2022-07-27
- FDA Inspection 1026865 - 2017-09-19
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