FDA Cites Florida Compounder for Unapproved Drugs

Complete Pharmacy and Medical Solutions received a Form 483 from the FDA with seven observations stemming from a Jan. 9-23 inspection at its compounding facility in Miami Lakes, Florida.

The agency found that the facility was compounding drugs that were not on the agency’s drug shortage list or that contain a bulk substance that’s also a component of an approved drug and that offers no clinical advantage. Drugs cited included an injectable hydroxocobalamin formula, a hydroquinone/fluocinolone/tretinoin cream and a testosterone cypionate injectable.

The firm also failed to conduct stability testing on sterile and non-sterile product. “Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use,” the investigator said.