Deciem Inc. – FDA Inspection, Apr 2, 2026

Record Details

This FDA Inspection record concerns Deciem Inc., with an inspection on April 2, 2026, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Deciem Inc.
Inspection Date: April 2, 2026
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Wayne D. Mcgrath

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ID · 7c260537-d279-4a23-9aab-219029941788

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1310582
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.170(b)Annual visual exams of drug products
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.67(b)Written procedures not established/followed
21 CFR 211.68(b)Backup file not maintained
21 CFR 211.68(b)Computer control of master formula records

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FDA Inspection

Deciem Inc.April 2, 2026