Laurus Generics, Inc. – FDA Inspection, Jan 21, 2025

Record Details

This FDA Inspection record concerns Laurus Generics, Inc., with an inspection on January 21, 2025, issued by the New Jersey District Office, covering human drugs.

Company: Laurus Generics, Inc.
Inspection Date: January 21, 2025
Product Type: Human Drugs
Office: New Jersey District Office
Person: Jay B. Shah (FDA Associated Person)

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ID · a27ed999-2642-4cbf-a36b-b0888ebba067

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1250139
FDA center: Human Drugs
Project area: Postmarketing Surveillance and Epidemiology: Human Drugs
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 314.80(b)Failure to develop written procedures

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FDA Inspection

Laurus Generics, Inc.January 21, 2025