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FDA Inspection
•CBI Laboratories, Inc. dba Voyant Beauty LLC.•December 5, 2017

CBI Laboratories, Inc. dba Voyant Beauty LLC. – FDA Inspection, Dec 5, 2017

Record Details

This FDA Inspection record concerns CBI Laboratories, Inc. dba Voyant Beauty LLC., with an inspection on December 5, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
CBI Laboratories, Inc. dba Voyant Beauty LLC.
Inspection Date
December 5, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Patty P. Kaewussdangkul (FDA Associated Person)
View Company Profile

ID · 6dd46901-442b-4285-9c57-729fe21c8f09

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1033859
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  2. 21 CFR 211.165(a)Testing and release for distribution
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed
  4. 21 CFR 211.166(a)Written program not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of CBI Laboratories, Inc. dba Voyant Beauty LLC.

4
DateClassificationOfficeProject area
July 8, 2021OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 14, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 14, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 1, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for CBI Laboratories, Inc. dba Voyant Beauty LLC.
  • FDA Inspection 1145678 - 2021-07-08
  • FDA Inspection 1089889 - 2019-05-14
  • FDA Inspection 862837 - 2014-02-14
  • FDA Inspection 584934 - 2009-05-01

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