# FDA 483 - Berkshire Sterile Manufacturing, LLC - October 27, 2020

Source: https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/41216297-9af0-4848-860e-e6b26912edd0

> FDA 483 for Berkshire Sterile Manufacturing, LLC on October 27, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2020-10-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Berkshire Sterile Manufacturing, Inc. in Lee, MA, was inspected and cited for significant deficiencies in its quality control unit, particularly regarding deviation reporting and OOS investigations. The inspection also revealed issues with equipment cleaning procedures, microbiological contamination prevention, yield determination, and the validation of electronic records used for drug product specifications. These findings indicate a need for comprehensive improvements in the firm's quality management system.

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## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.keypedia.com/companies/berkshire-sterile-manufacturing-llc/122082ed-d7d0-478b-8280-8fd8bad790b2

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248