Neutraderm Inc. – FDA Inspection, Jul 22, 2016

Record Details

This FDA Inspection record concerns Neutraderm Inc., with an inspection on July 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Neutraderm Inc.
Inspection Date: July 22, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · d4662137-08f3-4338-9b1b-ffe6a0000e83

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 980025
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.22(b)Adequate lab facilities not available
21 CFR 211.84(d)(1)Component identity verification
21 CFR 211.165(f)Failing drug products not rejected
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(a)Following/documenting laboratory controls
21 CFR 211.25(a)GMP Training Frequency
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.160(b)(2)In-process samples representative, identified properly
21 CFR 211.84(c)(4)Composite sample top/middle/bottom

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Other FDA inspections of Neutraderm Inc.

Date	Classification	Office	Project area
June 15, 2026	Not classified	Los Angeles District Office
December 9, 2022	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
September 14, 2018	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
April 26, 2013	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
December 2, 2011	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance