# FDA 483 - Berkshire Sterile Manufacturing, LLC - August 25, 2023

Source: https://www.keypedia.com/records/483/berkshire-sterile-manufacturing-llc/dfe773a7-405c-4d31-aaf3-9e6ff342adc9

> FDA 483 for Berkshire Sterile Manufacturing, LLC on August 25, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berkshire Sterile Manufacturing, LLC
- Inspection Date: 2023-08-25
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Berkshire Sterile Manufacturing, Inc. in Lee, MA, was inspected regarding its sterile drug manufacturing operations. The inspection revealed a critical lapse in procedures designed to prevent microbiological contamination, specifically an operator blocking laminar airflow during aseptic vial filling and stoppering of PEDMARK Sodium Thiosulphate Injection. This indicates a significant concern for maintaining sterility during production.

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## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

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