Inspection Record

Hikma Pharmaceuticals USA Inc. — FDA 483 Findings

US FDAInspected 2024-06-12Published 2024-07-09 3 findingsQuality unit oversightLaboratory and QC controlsContamination control

Inspectors Christina K Theodorou · Christian F Gomez Lugo · Yoriann Cabrera Bartolomei and 1 moreThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

2Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

3Contamination control

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.

About this record

Extracted automatically from the document US FDA published on 2024-07-09. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Hikma Pharmaceuticals USA Inc. company profile — full history US FDA documents, 2024 Go to Findings search