Advance Pharmaceutical Inc – FDA Inspection, Jan 11, 2013

Record Details

This FDA Inspection record concerns Advance Pharmaceutical Inc, with an inspection on January 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Advance Pharmaceutical Inc
Inspection Date: January 11, 2013
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 78391bfc-7d8c-4604-98c7-cf5a551927f8

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 813599
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.170(a)Active ingredient retained sample kept
21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
21 CFR 211.142(b)Storage under appropriate conditions
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(b)(4)Establishment of calibration procedures
21 CFR 211.130Procedures are written, and followed
21 CFR 211.84(d)(2)Reports of Analysis (Components)
21 CFR 211.170(b)Annual visual exams of drug products
21 CFR 211.84(c)(5)Identifying Sample Containers

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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