FDA Inspection
Micro Quality Labs IncMicro Quality Labs Inc – FDA Inspection, Nov 6, 2014
Record Details
This FDA Inspection record concerns Micro Quality Labs Inc, with an inspection on November 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Micro Quality Labs Inc
- Inspection Date
- November 6, 2014
- Product Type
- Drugs
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ID · ecef77a8-85a3-4315-a22e-82a3f04e134d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904931
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.182Written records kept in individual logs
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