Inspection Record

University Of Pittsburgh Medical Center Centralized Packaging — FDA 483 Findings

US FDAInspected 2025-08-14Published 2026-07-27 3 findingsEquipment and facilityDeviation, CAPA, and investigationStability and storage

Inspectors Yaharn SuThe inspectors who signed the published document.Inspector lookup

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Findings

1Equipment and facility

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

3Stability and storage

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

About this record

Extracted automatically from the document US FDA published on 2026-07-27. 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.

University Of Pittsburgh Medical Center Centralized Packaging company profile — full history US FDA documents, 2026 Go to Findings search