FDA Inspection
Laboratorios Cosmeticos Lamarvi, SALaboratorios Cosmeticos Lamarvi, SA – FDA Inspection, Sep 22, 2016
Record Details
This FDA Inspection record concerns Laboratorios Cosmeticos Lamarvi, SA, with an inspection on September 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 22, 2016
- Product Type
- Drugs
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ID · c9c46efb-0659-42b7-a0d4-b2e6aea5d3dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990179
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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