Advance Pharmaceutical Inc – FDA Inspection, Dec 9, 2011

Record Details

This FDA Inspection record concerns Advance Pharmaceutical Inc, with an inspection on December 9, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Advance Pharmaceutical Inc
Inspection Date: December 9, 2011
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 9e98cbd4-ba1c-42ca-8ff6-e15fdd3a4559

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 756490
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
21 CFR 211.110(b)In-process materials specifications
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.166(a)(4)Testing in same container - closure system
21 CFR 211.166(a)(2)Stability sample storage conditions described
21 CFR 211.166(a)(3)Valid stability test methods
21 CFR 211.67(b)Written procedures not established/followed

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Other FDA inspections of Advance Pharmaceutical Inc

Date	Classification	Office	Project area
February 27, 2025	VAI	New York District Office	Drug Quality Assurance
December 13, 2018	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
July 6, 2017	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
December 2, 2015	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
March 6, 2015	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance