FDA Inspection
Frike Cosmetic AGFrike Cosmetic AG – FDA Inspection, Sep 8, 2016
Record Details
This FDA Inspection record concerns Frike Cosmetic AG, with an inspection on September 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Frike Cosmetic AG
- Inspection Date
- September 8, 2016
- Product Type
- Drugs
View Company Profile
ID · b31683a0-36ac-4cec-b19a-4a953ecf8076
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986678
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Written record of investigation incomplete
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