483
BELLFXBELLFX – FDA 483, Mar 31, 2022
Record Details
During an inspection, BELLFX, a medical device manufacturer in San Fernando, CA, was cited for a single observation related to inadequate documentation of process validation activities. The firm failed to document the installation, operational, and performance qualification activities and results for CNC machines used in manufacturing Class II medical devices.
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ID · ce4e7c62-125a-48a3-aafb-b060b78b2569
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