Inspection Record

SCA Pharmaceuticals — FDA 483 Findings

US FDAInspected 2023-05-17Published 2023-07-19 4 findingsDeviation, CAPA, and investigationAseptic processing and sterility assuranceEquipment and facility

Inspectors Lisa R HilliardThe inspectors who signed the published document.Inspector lookup

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high- efficiency particulate air filters under positive pressure.

4Equipment and facility

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.

About this record

Extracted automatically from the document US FDA published on 2023-07-19. 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.

Other records for this company

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SCA Pharmaceuticals company profile — full history US FDA documents, 2023 Go to Findings search