OurPharma LLC — FDA 483 Findings

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

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(8) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Your fir m failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(1 0)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).