Conseal International, Inc. – FDA Inspection, Apr 5, 2018

Record Details

This FDA Inspection record concerns Conseal International, Inc., with an inspection on April 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Conseal International, Inc.
Inspection Date: April 5, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Diane M. Biron (Issuing Officer)
Justine M. Corson (FDA Associated Person)

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ID · 8a75255e-8de6-4ed2-b28c-b993664bd48a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1046981
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.137(d)Expiration date location on labeling
21 CFR 820.20(e)Quality System Procedures
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 211.165(a)Testing and release for distribution

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FDA Inspection

Conseal International, Inc.April 5, 2018