Berkshire Sterile Manufacturing, LLCAugust 25, 2023

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

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Record Details

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.

Company: Berkshire Sterile Manufacturing, LLC
Inspection Date: August 25, 2023
Product Type: Drugs
Office: Division of Northeast Imports
Person: Jonathan G. Matrisciano (Program Division Director/District Director)

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ID · dfe773a7-405c-4d31-aaf3-9e6ff342adc9