483
Kal-Med LLCFDA 483 - Kal-Med LLC - March 31, 2023
Record Details
Kal-Med LLC, a medical device specification developer in Kensington, CT, was inspected by the FDA. The inspection revealed significant deficiencies in quality system procedures, including inadequate controls for purchased products and services, incomplete device history records lacking unique device identifiers, and a failure to establish proper procedures for design changes, particularly concerning product packaging.
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ID · 81920716-8706-480c-85a9-185563887fca