483
Brammer Bio MA, LLCBrammer Bio MA, LLC – FDA 483, Feb 10, 2021
Record Details
Brammer Bio MA, LLC in Cambridge, MA, a viral vector manufacturer, received a Form 483 with three observations during an inspection from February 1-10, 2021. The observations highlight significant issues with contamination control in equipment and facilities, inadequate employee training, and poor control over production records, indicating potential risks to product quality and integrity.
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ID · 2161d805-e248-4655-a1a9-2a74e7d43e16
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