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FDA Inspection
•B. Kolormakeup & Skincare SpA Societa Benefit•September 23, 2016

B. Kolormakeup & Skincare SpA Societa Benefit – FDA Inspection, Sep 23, 2016

Record Details

This FDA Inspection record concerns B. Kolormakeup & Skincare SpA Societa Benefit, with an inspection on September 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
B. Kolormakeup & Skincare SpA Societa Benefit
Inspection Date
September 23, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 868bc532-2dcc-4d3c-bb9e-2c5fae51e18e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
988223
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
  2. 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
  3. 21 CFR 211.100(a)Absence of Written Procedures
  4. 21 CFR 211.182Written records kept in individual logs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of B. Kolormakeup & Skincare SpA Societa Benefit

1
DateClassificationOfficeProject area
September 23, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for B. Kolormakeup & Skincare SpA Societa Benefit
  • FDA Inspection 988268 - 2016-09-23

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