Multiple Violations at Farmakeio Outsourcing

A 10/22-10/30/19 FDA inspection at Farmakeio Outsourcing, Southlake, TX, determined that the drug products produced at the outsourcing facility failed to meet the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the act. A 7/29 Warning Letter says specific violations involved unapproved new drug products and misbranded drug products.

FDA says the company’s response to an FDA-483 dated 11/4/19 contained proposed corrective actions that do not appear to be adequate. It cites a standard operating procedure for adverse event reporting that does not appear to adequately address the topic.

Farmakeio was told to take prompt action to correct the violations and prevent their recurrence and to submit a list of specific steps being taken to address the violations with documentation of each step and a timetable for completing the work.