FDA 483 - FARMAKEIO OUTSOURCING LLC - October 30, 2019

On October 30, 2019, the FDA issued a Form 483 to Farmakeio Outsourcing LLC in Southlake, TX, following an inspection from October 22-30, 2019. The inspection, conducted by Investigator Francis A. Guidry, identified three observations related to the firm's outsourcing facility operations.

Observation 1 noted that drug product labels did not include the required statement, "This is a compounded drug," as mandated by section 503B(a)(10)(A). This deficiency was observed on labels for various strengths of Testosterone/Triamcinolone Pellets, Estradiol Pellets, and Testosterone Pellets.

Observation 2 indicated that the firm compounded drugs essentially copied from approved drugs, violating sections 503B(a)(5) and 503B(d)(2). Specifically, the firm compounded Testosterone Pellets in multiple strengths (12.5 mg, 25 mg, 37.5 mg, 50 mg, 62.5 mg, 87.5 mg, 100 mg, and 200 mg) that were either identical or nearly identical to approved drugs not on the drug shortage list, or contained bulk drug substances of approved drugs without a clinically significant difference.

Observation 3 cited deficiencies in the environmental monitoring system for aseptic processing areas. The firm was not monitoring