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

Source: https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/0242d85d-cd8d-446f-8097-deda3e11a05e

> FDA 483 for Berkshire Sterile Manufacturing, LLC on May 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2022-05-23
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Documents

- [EIR - 2021-10-15](https://www.keypedia.com/records/eir/berkshire-sterile-manufacturing-llc/012a27c7-8b9d-4727-b75a-0e5804cad8d1)
- [483 - 2023-08-25](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/dfe773a7-405c-4d31-aaf3-9e6ff342adc9)
- [483 - 2020-10-27](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/41216297-9af0-4848-860e-e6b26912edd0)
- [483 - 2024-06-12](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/03ad202c-e3c8-476b-8d4f-4aeddef827f2)
- [483 - 2026-03-05](https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/ff12db27-ddb1-4962-8899-635e77cc23e0)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94