FDA WARNING_LETTER - Edge Pharma, LLC - August 20, 2014

On November 12, 2015, the FDA issued a Warning Letter to Edge Pharmacy Services, L.L.C., an outsourcing facility registered under section 503B of the FDCA. An inspection from July 22 to August 20, 2014, revealed serious deficiencies in sterile drug production, posing patient risks.

Violations include: - **Adulterated Drug Products:** Products were prepared under insanitary conditions (Section 501(a)(2)(A) FDCA) and failed to meet CGMP requirements (Section 501(a)(2)(B) FDCA). Specifically, the firm failed to demonstrate adequate protection of ISO 5 areas, lacked written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)), had an inadequate environmental monitoring system (21 CFR 211.42(c)(10)(iv)), and failed to test components for conformity (21 CFR 211.84(d)(2)). - **Unapproved New Drug Products:** The firm lacked FDA-approved applications for its drug products (Sections 301(d) and 505(a) FDCA). - **Misbranded Drug Products:** Labels lacked adequate directions for use for products not amenable to self-diagnosis (Section 502(f)(1) FDCA