Belcher Pharmaceuticals LLC — FDA 483 Findings

Your outsourcing facility has not submitted a report to FDA identifying a product compollllded during the previous six months as required by section 503B(b )(2)(A) ofthe Federal Food, Dmg, and Cosmetic Act (FD&C Act).

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assm·e that drug products conform to appropriate standards of identity, strength, quality and purity y Specifically, your firm failed to conduct testing for impurities as part of your finished product specification requirements prior to batch release for all strengths of Testosterone pellets (12.5mg, 37.5mg, 50mg, 100mg and 225mg) therefore your firm is unable to ensure degradants such as Androstenedione (Androst-4-ene-3,17-dione), unknown and unspecified related substances can be detected.

Each batch of drug product required to be free of objectionable niicroorganisms is not tested through appropriate laboratory testing.

Each batch of controlled-release dosage form drug product is not laboratory tested to detemiine conformance to the specifications for the rate of release for each active ingredient.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(IO)(A) ofthe Federal Food, Drug and Cosmetic Act (FD&C Act).