FDA Inspection 1257639 - MAK PHARMA USA LLC - December 30, 2024

Record Details

This FDA Inspection record concerns MAK PHARMA USA LLC, with an inspection on December 30, 2024, issued by the New Jersey District Office, covering human drugs.

Company: MAK PHARMA USA LLC
Inspection Date: December 30, 2024
Product Type: Human Drugs
Office: New Jersey District Office
Person: Frederick Razzaghi (FDA Associated Person)

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ID · 550bcea2-7687-4798-b2dc-8f05257c916a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1257639
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.67(b)Written procedures not established/followed

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FDA Inspection

MAK PHARMA USA LLCDecember 30, 2024