FDA Inspection
Tecnologia Cosmetica Export & Import, S.A. DE C.V.Tecnologia Cosmetica Export & Import, S.A. DE C.V. – FDA Inspection, Oct 16, 2015
Record Details
This FDA Inspection record concerns Tecnologia Cosmetica Export & Import, S.A. DE C.V., with an inspection on October 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 16, 2015
- Product Type
- Drugs
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ID · 4293cd06-311a-4ad2-8727-5af3b30a91c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948201
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Written Procedures Not Followed
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