FDA Warns 4 Device Manufacturers for CGMP Deviations, No Reporting Procedures
The Food and Drug Administration posted warning letters Sept. 4 it sent to device manufacturers in Tunisia, France and China threatening denial of premarket approval applications, and another warning letter to a device manufacturer in Taiwan for a lack of Medical Device Reporting.
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In a warning letter dated Aug. 3 (here), FDA said an inspection revealed Tunisian manufacturer Boukhari Prince Medical’s devices are adulterated because of violations of current good manufacturing practice requirements (CGMP) of the Quality System regulation. FDA sent similar letters to Prince Medical of France (here) and Sure On Industries of China (here) on Aug. 6. All three of the warning letters said premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
FDA also sent a warning letter to Pihsiang Machinery Manufacturing Company Limited of Taiwan on Aug. 15 (here). According to FDA, Pihsiang’s devices are misbranded because the firm failed to develop, maintain, and implement written Medical Device Reporting procedures. No consequences were specified by FDA in the letter.