Whitney Labs LP – FDA Inspection, Jan 26, 2012

Record Details

This FDA Inspection record concerns Whitney Labs LP, with an inspection on January 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Whitney Labs LP
Inspection Date: January 26, 2012
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · e496b317-9438-4415-bba6-f427e02e0bfa

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 762655
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.100(b)Procedure Deviations Recorded and Justified
21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.170(b)Reserve samples identified, representative, stored
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.80(a)Procedures To Be in Writing
21 CFR 211.67(b)Written procedures not established/followed

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Other FDA inspections of Whitney Labs LP

Date	Classification	Office	Project area
March 31, 2015	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
July 10, 2013	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
November 9, 2010	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance