FDA Inspection
Al.Ma CosmeticsAl.Ma Cosmetics – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Al.Ma Cosmetics, with an inspection on September 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Angela E. Glenn (Issuing Officer)
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ID · b9318969-2607-43af-b1db-988b5fe93cb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024482
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
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