483
Berkshire Sterile Manufacturing, LLCFDA 483 - Berkshire Sterile Manufacturing, LLC - October 21, 2024
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Record Details
Berkshire Sterile Manufacturing in Lee, MA, was inspected from October 14-21, 2024, and received eight observations primarily related to significant deficiencies in aseptic processing, environmental monitoring, and quality control. The findings indicate a high risk of microbial contamination and product quality issues due to inadequate procedures, training, and facility maintenance.
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ID · 1ff36da5-c5f5-408a-ad9b-f8e760d79860