Eye drop producer KC Pharmaceuticals receives FDA warning letter
The FDA sent a warning letter to California-based eye drop manufacturer KC Pharmaceuticals citing several issues related to the company’s quality system.
In the warning letter issued at the beginning of August, regulators said KC didn’t properly perform smoke studies for its aseptic processing lines or investigate and sufficiently address media fill failures on its filling lines. It also noted that KC’s “aseptic processing operation is inadequately designed to prevent contamination of your ophthalmic drug products.”
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