FDA 483 - Belcher Pharmaceuticals, LLC - August 16, 2024

The FDA Form 483 details multiple objectionable conditions at an outsourcing facility compounding Testosterone pellets (12.5mg, 37.5mg, 50mg, 100mg, 225mg).

Observation 1 states the facility failed to conduct dissolution testing for all strengths of Testosterone pellets prior to batch release, preventing assurance of reproducible API release rates and pellet integrity. Several specific batches of 100mg, 37.5mg, and 50mg Testosterone pellets were released without this testing.

Observation 3 notes a lack of scientifically sound specifications and test procedures. Specifically, the firm failed to test for impurities, including Androstenedione and other related substances, in finished Testosterone pellet products prior to release, impacting assurance of purity.

Observation 5 identifies non-compliance with labeling requirements under section 503B(a)(10)(A) of the FD&C Act. Labels for Testosterone Pellets (37.5mg, 50mg, 100mg, 225mg) lacked the statement "This is a compounded drug," the outsourcing facility's phone number, and storage/handling instructions.

Observation 6 indicates the outsourcing facility failed to submit a required report to the FDA, as per section 503B(b)(2)(A) of the FD&C Act, identifying a product compounded in the previous six months. Specifically,