483
Sonogage IncSonogage Inc – FDA 483, Mar 21, 2018
Record Details
An FDA inspection of Sonogage Inc, a medical device manufacturer in Cleveland, OH, revealed significant deficiencies in process control procedures. The firm failed to establish manufacturing instructions for its pachometer devices and lacked adequate internal QC testing procedures. These issues indicate a lack of control over critical manufacturing processes.
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ID · a508ce6b-f4aa-4ec4-adc5-d24709a9fe01
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