FDA Inspection

TatesJuly 25, 2014

Tates – FDA Inspection, Jul 25, 2014

Record Details

This FDA Inspection record concerns Tates, with an inspection on July 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Tates
Inspection Date: July 25, 2014
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 43032a3b-5f13-4ab0-a67a-2f79f6ec43ca

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 892905
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.110(a)Control procedures fail to include the following
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.125(f)Procedures Written and Followed
21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.186(a)Written procedures followed
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.56(b)Written sanitation procedures lacking

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