Inspection Record

JHP Pharmaceuticals, Inc. — FDA 483 Findings

US FDAInspected 2015-07-23Published 2024-01-17 3 findingsEquipment and facilityQuality unit oversightDeviation, CAPA, and investigation

Inspectors Sarah M. Napier · Rebecca E. DombrowskiThe inspectors who signed the published document.Inspector lookup

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

Findings

1Equipment and facility

Written procedures are not established and followed for the cleaning and maintenance ofequipment, including utensils, used in the manufacture , processing, packing or holding ofa drug product.

2Quality unit oversight

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

3Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

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