Inspection Record

SCA Pharmaceuticals LLC — FDA 483 Findings

US FDAInspected 2026-03-13Published 2026-05-08 3 findingsDeviation, CAPA, and investigationAseptic processing and sterility assuranceEquipment and facility

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

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

3Equipment and facility

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

About this record

Extracted automatically from the document US FDA published on 2026-05-08. 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

2025-10-30 · 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 LLC company profile — full history US FDA documents, 2026 Go to Findings search