483
MEDISIZE CZMEDISIZE CZ – FDA 483, Apr 3, 2023
Record Details
An FDA inspection of Medisize CZ in Trhove Sviny, Czech Republic, identified four observations related to its device manufacturing operations. The firm was cited for inadequate procedures concerning equipment calibration, environmental controls, and the documentation of corrective and preventive actions. Additionally, deficiencies were noted in the established procedures for handling customer complaints.
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ID · 40723a96-c308-4fe1-b9c0-708a8628bebd
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