Inspection Record

Berkshire Sterile Manufacturing — FDA 483 Findings

US FDAInspected 2023-01-20Published 2026-07-15 3 findingsMaterial and supplier controlDeviation, CAPA, and investigationCleaning validation

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

Findings

1Material and supplier control

The responsibilities and procedures applicable to raw material management are not fully followed.

2Deviation, CAPA, and investigation

Written procedures lack sufficient detail describing the handling of deviations.

3Cleaning validation

Cleaning procedures are not est ablis hed, Specifically,

About this record

Extracted automatically from the document US FDA published on 2026-07-15. 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.

Berkshire Sterile Manufacturing company profile — full history US FDA documents, 2026 Go to Findings search