483
Brammer Bio MA, LLCBrammer Bio MA, LLC – FDA 483, Feb 10, 2021
Record Details
Brammer Bio MA, LLC, a viral vector manufacturer in Somerville, MA, was cited for a significant quality control failure. The firm shipped rejected and un-dispositioned lentiviral vector material to a client without the knowledge or approval of its quality unit. This lapse involved multiple lots of material over several months, indicating a failure in ensuring proper disposition and authorization before product release.
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ID · 7e2cff7f-ec19-4630-bef4-eea4e3155ad7
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