FDA Inspection
Micro Labs LimitedMicro Labs Limited – FDA Inspection, Feb 7, 2025
Record Details
This FDA Inspection record concerns Micro Labs Limited, with an inspection on February 7, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 38f8fd47-1d31-4589-8300-ba264571c32f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260741
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Micro Labs Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Micro Labs Limited
- FDA Inspection 1137087 - 2020-01-24
- FDA Inspection 1050472 - 2018-03-16
- FDA Inspection 960742 - 2015-12-18
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