US FDA warning: Contamination risk at CDMO in North Carolina
The US Food and Drug Administration (FDA) cited good manufacturing practice (GMP) violations in the warning letter – issued earlier today – following an inspection at Ei LLC’s facility in North Carolina in October last year.
The contract development and manufacturing organisation (CDMO) makes finished pharmaceuticals including liquid and semi-solid topical drug products.
According to the letter, Ei LLC did not provide separate “defined areas” for the manufacture of topical drugs and pesticides.
“It is unacceptable as a matter of cGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination,” said the Agency.
In addition, records revealed the firm had manufactured a pesticide and human drugs using shared equipment, said the FDA.
More specifically, when an out-of-specification result showed an impurity in a drug product, Eli LLC failed to put adequate corrective and preventive actions in place.
“Our investigator also found evidence of contamination from unknown impurities in six engineering batches of clobetasol propionate 0.05% topical spray," according to the FDA. “Your produced these drug products using the same equipment and facilities that you use for commercial manufacturing."
The FDA has recommended Eli LLC hire an external consultant to address these GMP violations, and demonstrate it has adequately validated cleaning procedures to prevent cross-contamination between drug products.
Ei LLC did not respond to a request for comment before the time of publication.
