FDAnews Device Daily Bulletin

GMPs, Complaint Handling Cited in Warning Letter

Dec. 29, 2009
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Chinese manufacturer Huaiyin Medical Instruments is cited for good manufacturing practice (GMP) violations in an FDA warning letter. During an FDA inspection of its Huaian, China, plant in March and April, the company did not have validation data for two sterilizers, and the data it provided didn’t identify the sterilizers on which the validation was performed, according to the Nov. 20 letter posted to the FDA website recently.
Devices & Diagnostics Letter