FDA Inspection
Renu Laboratories, Inc.Renu Laboratories, Inc. – FDA Inspection, Jul 27, 2022
Record Details
This FDA Inspection record concerns Renu Laboratories, Inc., with an inspection on July 27, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Renu Laboratories, Inc.
- Inspection Date
- July 27, 2022
- Product Type
- Drugs
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ID · 8c5c04ef-3337-456b-9125-01258d71a45c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1175495
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.111Establishment of time limitations
Full citation text and observation details available on the Dashboard.
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 |
| September 19, 2017 | 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 1026865 - 2017-09-19
- FDA Inspection 760599 - 2011-12-28
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