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FDA Inspection
•Flawless Beauty and Skin•May 16, 2014

Flawless Beauty and Skin – FDA Inspection, May 16, 2014

Record Details

This FDA Inspection record concerns Flawless Beauty and Skin, with an inspection on May 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Flawless Beauty and Skin
Inspection Date
May 16, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ff600923-d8eb-4fb2-a69b-6f14427043cd

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
879923
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

10
  1. 21 CFR 211.188Prepared for each batch, include complete information
  2. 21 CFR 211.198(a)Complaint Handling Procedure
  3. 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
  4. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  5. 21 CFR 211.150(b)Distribution Recall System
  6. 21 CFR 211.100(a)Absence of Written Procedures
  7. 21 CFR 211.22(a)Lack of quality control unit
  8. 21 CFR 211.166(a)Lack of written stability program
  9. 21 CFR 111.553Written procedures - product complaint
  10. 21 CFR 111.75(c)Specifications met - verify; finished batch

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Flawless Beauty and Skin

2
DateClassificationOfficeProject area
January 10, 2018OAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
May 26, 2015OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Flawless Beauty and Skin
  • FDA Inspection 1037221 - 2018-01-10
  • FDA Inspection 928402 - 2015-05-26

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