# FDA 483 - Berkshire Sterile Manufacturing, LLC - October 21, 2024

Source: https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/72c404f5-4b36-435f-b842-75cb8d607994

> FDA 483 for Berkshire Sterile Manufacturing, LLC on October 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2024-10-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Berkshire Sterile Manufacturing in Lee, MA, revealed significant deficiencies in their sterile drug product manufacturing operations. Observations included inadequate aseptic processing procedures, insufficient environmental monitoring, and a lack of proper investigation into quality events. These findings indicate a high risk of microbial contamination and compromised product quality for their sterile injectable drug products.

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## Related Officers

- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)
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Company: https://www.keypedia.com/companies/berkshire-sterile-manufacturing-llc/122082ed-d7d0-478b-8280-8fd8bad790b2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4