Venezuelan Company Gets GMP Warning Over Sterile Drugs

Laboratories L.O. Oftalmi has received an FDA warning letter citing GMP violations for drug products purporting to be sterile. The Caracas, Venezuela, company’s media fill studies suggest its manufacturing process is not under control, according to the May 12 letter posted recently online. Oftalmi is committed to addressing the issues in a timely manner, company spokesman Jose Torres said. The company has recalled all OTC ophthalmic and nasal products manufactured at the facility and distributed in the U.S., he added.
Drug GMP Report