FDA 483 - F.H. Investments Inc. - November 08, 2024

The FDA Form 483 details five observations from an inspection of a facility producing sterile compounded drug pellets.

**Observation 1** notes a failure to thoroughly review unexplained discrepancies, specifically regarding customer complaints for sterile compounded drug pellets. These complaints, dated from September to October 2024, include issues such as pellets not fitting trocar kits, multiple units received as powder, pellets stuck in vials, pellets crumbling, variable color and shape, and pellets disintegrating upon opening. Affected products include various strengths of Testosterone and Estradiol pellets.

**Observation 2** indicates that each batch of controlled-release dosage form drug product is not laboratory tested for conformance to release rate specifications. The firm failed to conduct dissolution testing as part of finished product specification requirements prior to batch release for numerous Testosterone and Estradiol pellet strengths, preventing assurance of proper dissolution, integrity, and reproducible active pharmaceutical ingredient release.

**Observation 3** states that equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination. The equipment cleaning process has not been validated to prevent cross-contamination between hazardous and highly-potent hormone APIs (testosterone and estradiol) when using non-dedicated equipment like pellet presses, containment hoods, analytical balances, and calipers. An example cited is inadequate cleaning of a pellet press and containment hood after Testosterone 100 mg pellet production on October 29, 2024, leaving a white residue.

**Observation 4** identifies