Advance Pharmaceutical Inc – FDA Inspection, Dec 2, 2015

Record Details

This FDA Inspection record concerns Advance Pharmaceutical Inc, with an inspection on December 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Advance Pharmaceutical Inc
Inspection Date: December 2, 2015
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 59a628b5-2389-4958-b818-94ca8b535fd3

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 953151
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.170(b)Reserve samples identified, representative, stored
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.22(d)Procedures not in writing, fully followed

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Other FDA inspections of Advance Pharmaceutical Inc

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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
March 6, 2015	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
December 19, 2013	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance