Crown Laboratories Inc – FDA Inspection, Mar 9, 2012

Record Details

This FDA Inspection record concerns Crown Laboratories Inc, with an inspection on March 9, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Crown Laboratories Inc
Inspection Date: March 9, 2012
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 5e50c1a5-9300-4e27-8604-bcb3b3e84349

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 772058
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.110(a)Control procedures fail to include the following
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.80(b)Handling and Storage to Prevent Contamination
21 CFR 211.67(b)Written procedures fail to include

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Other FDA inspections of Crown Laboratories Inc

Date	Classification	Office	Project area
September 19, 2025	VAI	New Orleans District Office	Drug Quality Assurance
March 15, 2018	NAI	Center for Drug Evaluation and Research	Drug Quality Assurance
February 15, 2018	NAI	Center for Drug Evaluation and Research	Bioresearch Monitoring
April 8, 2016	VAI	Center for Drug Evaluation and Research	Bioresearch Monitoring
September 24, 2014	OAI	Center for Drug Evaluation and Research	Unapproved and Misbranded Drugs