Asept Pak Inc. – FDA Inspection, Dec 2, 2011

Record Details

This FDA Inspection record concerns Asept Pak Inc., with an inspection on December 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Asept Pak Inc.
Inspection Date: December 2, 2011
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · b876b952-f520-4146-9299-ccce83d72e61

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 755886
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.165(d)Acceptance criteria for sampling & testing
21 CFR 211.58Buildings not maintained in good state of repair
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.46(b)Equipment for Environmental Control
21 CFR 211.110(b)In-process materials specifications testing
21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.170(b)(1)Retention time of reserve samples, in general
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.166(a)Lack of written stability program

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Other FDA inspections of Asept Pak Inc.

Date	Classification	Office	Project area
September 19, 2024	NAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
August 4, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
December 20, 2019	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
April 21, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 24, 2013	VAI	Center for Devices and Radiological Health	Compliance: Devices