FDA Inspection
Renu Laboratories, Inc.Renu Laboratories, Inc. – FDA Inspection, Sep 19, 2017
Record Details
This FDA Inspection record concerns Renu Laboratories, Inc., with an inspection on September 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4925a1e1-087d-4fe5-a2c0-deae66aed610
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(2)In-process sample representation/identification
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.111Establishment of time limitations
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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 |
| December 28, 2011 | 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 760599 - 2011-12-28
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