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FDA Inspection
•CBI Laboratories, Inc. dba Voyant Beauty LLC.•May 14, 2019

CBI Laboratories, Inc. dba Voyant Beauty LLC. – FDA Inspection, May 14, 2019

Record Details

This FDA Inspection record concerns CBI Laboratories, Inc. dba Voyant Beauty LLC., with an inspection on May 14, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
CBI Laboratories, Inc. dba Voyant Beauty LLC.
Inspection Date
May 14, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Michelle A. Krayer
  • Patty P. Kaewussdangkul (FDA Associated Person)
View Company Profile

ID · d888ea07-479e-4e61-835e-41fe142b6252

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1089889
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 211.63Equipment Design, Size and Location
  2. 21 CFR 211.180(e)Records reviewed annually
  3. 21 CFR 211.42(c)(1)Incoming material area
  4. 21 CFR 211.100(a)Absence of Written Procedures
  5. 21 CFR 211.22(d)Procedures not in writing, fully followed
  6. 21 CFR 211.67(b)Written procedures fail to include

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
December 5, 2017OAICenter 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 1033859 - 2017-12-05
  • FDA Inspection 862837 - 2014-02-14
  • FDA Inspection 584934 - 2009-05-01

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