Inspection Record

SCA Pharmaceuticals Inc — FDA 483 Findings

US FDAInspected 2025-10-30Published 2025-12-18 3 findingsAseptic processing and sterility assuranceLaboratory and QC controlsDeviation, CAPA, and investigation

Inspectors Demario L WallsThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

2Laboratory and QC controls

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

3Deviation, CAPA, and investigation

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

About this record

Extracted automatically from the document US FDA published on 2025-12-18. 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

2026-03-13 · US FDA · 3 findings2024-12-20 · US FDA · 7 findings2015-07-10 · US FDA · 7 findings2018-04-09 · US FDA · 8 findings2018-10-24 · US FDA · 10 findings2018-01-08 · US FDA · 6 findings
SCA Pharmaceuticals Inc company profile — full history US FDA documents, 2025 Go to Findings search