F.H. Investments Inc. – FDA 483, Jul 10, 2018

This FDA Form 483 document outlines observations made during an inspection of a facility manufacturing drug products, specifically testosterone and estradiol pellets. The inspection revealed two primary violations related to the prevention of microbiological contamination and laboratory controls.

Firstly, procedures designed to prevent microbiological contamination of sterile drug products were found to lack adequate validation of the sterilization process. During (b)(4) sterilization validation, the bioburden and sterility method validation and suitability testing used for dose verification testing were not performed using the firm's own testosterone and estradiol pellets. Additionally, the sterility and bioburden testing methods only evaluated the external surfaces of each implantable pellet, not the entirety.

Secondly, laboratory controls were cited for not including scientifically sound and appropriate test procedures to assure drug products conform to identity, strength, quality, and purity standards. Specifically, sterility testing of hormone pellets during (b)(4) only provided information for the exterior surfaces of the implantable pellets, with no evaluation of the entire pellet. These findings indicate deficiencies in the firm's quality system and manufacturing processes, particularly concerning the validation and testing of sterile drug products.