483
BRAINSPEC, INCBRAINSPEC, INC – FDA 483, Jun 24, 2026
Record Details
An FDA inspection of BRAINSPEC, INC in Framingham, MA, revealed significant deficiencies in their preventive action procedures related to the BrainSpec Core™ Software. The firm failed to establish and implement proper procedures, including ensuring they were approved before use and verifying the effectiveness of implemented actions. These findings indicate a lack of robust quality system controls.
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ID · a799859a-f455-4ffd-aaff-5a5202ba9263
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