HIKMA PHARMACEUTICALS USA INC. – FDA Inspection, Jul 13, 2026

Record Details

This FDA Inspection record concerns HIKMA PHARMACEUTICALS USA INC., with an inspection on July 13, 2026, issued by the New Jersey District Office, covering human drugs.

Company: HIKMA PHARMACEUTICALS USA INC.
Inspection Date: July 13, 2026
Product Type: Human Drugs
Office: New Jersey District Office
Person: Jay B. Shah (FDA Associated Person)

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ID · 2b9bbcb5-0b56-44ed-b708-f3cbbd8a563e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1286008
FDA center: Human Drugs
Project area: Postmarket Surv. and Epidemiology
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

HIKMA PHARMACEUTICALS USA INC.July 13, 2026