FDA Warns Korean Device Facility for CGMP, MDR Violations
The Food and Drug Administration warned Korean device manufacturer Mi Gwang Contact Lens Co. that its premarket approval applications and federal contracts may be refused for violations of current good manufacturing practice (CGMP) requirements. The warning letter also detailed violations…
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of the Medical Device Reporting regulation. FDA told the company to respond to the allegations with corrective actions within 15 days of receipt of the Nov. 13 letter.