FDA faults Japanese manufacturer with data breach, contaminated injectables
The FDA has come down hard on a Japanese manufacturer, with cGMP failures that include batch discrepancies left without investigation, data breaches left unaddressed and the manipulation of contact plate measurements.
Toyobo Co. received a warning letter on Aug. 19. If it cannot correct the violations, the FDA can refuse the import of drugs manufactured at the Shiga site into the US. Toyobo has 15 days to respond to the letter.
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