Wiley Chemists Inc. – FDA 483, Oct 2, 2013

This FDA Form 483 document details observations made during an inspection of a drug product manufacturing facility. The primary issue identified is the failure to perform appropriate laboratory testing for drug product release. Specifically, the firm does not conduct finished product testing for each lot of drug product distributed. Examples provided include the absence of assay potency testing for Testosterone T-10 mg/1 ml cream lot 2013060309, Dehydroepiandrosterone (DHEA) cream lot 2013060311, Estradiol E2-1 mg/1 ml cream lot 2013062063, Progesterone P4-20 mg/1 ml cream lot 2013062402, and Wiley Cortisol capsules lot 2013062402.

Furthermore, the document notes that the identity of each component of a drug product is not verified by conducting at least one test, including specific identity tests where available. The firm does not perform identity testing on active ingredient components used in the finished drug product. Examples cited include Testosterone USP, DHEA USP micronized, Estradiol USP micronized, Progesterone USP micronized, and Hydrocortisone USP, all used in various finished drug products without identity verification. These observations indicate deficiencies in the firm's quality control and release procedures, potentially impacting the safety, identity, strength, quality,