FDA Inspection
Micro Labs LimitedMicro Labs Limited – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Micro Labs Limited, with an inspection on March 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ded75b11-a501-4965-8a82-92025d7971e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Micro Labs Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | Office of Inspections and Investigations | |
| May 12, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2017 | Not classified | Office of Inspections and Investigations | |
| September 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 31, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Micro Labs Limited
- FDA Inspection 1322972 - 2026-06-30
- FDA Inspection 1205034 - 2023-05-12
- FDA Inspection 1028491 - 2017-03-28
- FDA Inspection 944854 - 2015-09-15
- FDA Inspection 793557 - 2012-07-31
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