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FDA Inspection
•Cosmaceutical Research Lab Inc.•October 12, 2024

Cosmaceutical Research Lab Inc. – FDA Inspection, Oct 12, 2024

Record Details

This FDA Inspection record concerns Cosmaceutical Research Lab Inc., with an inspection on October 12, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Cosmaceutical Research Lab Inc.
Inspection Date
October 12, 2024
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Arsen Karapetyan
View Company Profile

ID · 6d8b3f25-b45c-4085-9839-77680f39f019

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
1252506
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.160(b)Scientifically sound laboratory controls
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed
  5. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cosmaceutical Research Lab Inc.

3
DateClassificationOfficeProject area
June 10, 2022OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 15, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 23, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Cosmaceutical Research Lab Inc.
  • FDA Inspection 1173864 - 2022-06-10
  • FDA Inspection 1035040 - 2017-12-15
  • FDA Inspection 986769 - 2016-09-23

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