FDA Inspection
Ancorotti Cosmetics SrlAncorotti Cosmetics Srl – FDA Inspection, Sep 19, 2019
Record Details
This FDA Inspection record concerns Ancorotti Cosmetics Srl, with an inspection on September 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 23304e3f-24c1-4889-921f-20374b227b1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102272
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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