FDA Inspection
Quality Colors And Creams S.a. De C.v.Quality Colors And Creams S.a. De C.v. – FDA Inspection, Sep 15, 2014
Record Details
This FDA Inspection record concerns Quality Colors And Creams S.a. De C.v., with an inspection on September 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 15, 2014
- Product Type
- Drugs
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ID · 423c8ee5-9ac9-40e4-929d-96ed963d8c6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899611
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.110(a)Written in-process control procedures
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