FDA Directs 2 Foreign Device Cos. to Correct CGMP Violations
The Food and Drug Administration sent warning letters to two medical device manufacturers after FDA inspections that revealed non-compliance with the current good manufacturing practice requirements of the Quality System regulation. In a warning letter dated July 26, FDA warned…
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Royal King Infant Products of Thailand that its teething rings face detention without physical examination unless and/or until it corrects violations including, among other things, verification and corrective action procedures. FDA also sent a warning letter dated Aug. 1 to Compumedics Germany for similar reasons, but did not say the company’s offending imaging diagnostic systems are subject to detention without physical examination.