Berkshire Sterile Manufacturing, LLCMay 23, 2022

FDA 483 - Berkshire Sterile Manufacturing, LLC - May 23, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Berkshire Sterile Manufacturing, LLC

Record Details

An FDA inspection of Berkshire Sterile Manufacturing, LLC in Lee, MA, revealed significant deficiencies in their manufacturing processes and quality control. The firm lacked written procedures and supporting data for critical changes to manufacturing equipment and an expired terminal sterilization validation. Additionally, the company failed to conduct annual visual examinations of reserve drug product samples for signs of deterioration.

Company: Berkshire Sterile Manufacturing, LLC
Inspection Date: May 23, 2022
Product Type: Drugs
Office: Division of Northeast Imports
Person: Erik W. Koester (Investigator)

Open in Dashboard

ID · 0242d85d-cd8d-446f-8097-deda3e11a05e