Vitaminerals, Inc. – FDA Inspection, Aug 17, 2012

Record Details

This FDA Inspection record concerns Vitaminerals, Inc., with an inspection on August 17, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Vitaminerals, Inc.
Inspection Date: August 17, 2012
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 05d24c72-7711-4e43-8545-c08106e21d52

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 796009
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.58Buildings not maintained in good state of repair
21 CFR 211.142(b)Storage under appropriate conditions
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.194(a)(8)Second person sign off
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.188(b)(2)Identification of Equipment and Lines
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 111.27(d)Equipment - maintain, clean, sanitize
21 CFR 111.30(b)Equipment - automated - suitability
21 CFR 111.315(a)Criteria for establishing specifications

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Other FDA inspections of Vitaminerals, Inc.

Date	Classification	Office	Project area
December 23, 2016	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
May 6, 2016	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
April 20, 2011	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
June 4, 2009	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ