FDA WARNING_LETTER - Medaus, Inc. - March 22, 2013

On March 18-22, 2013, an FDA and Alabama State Board of Pharmacy inspection of Medaus, Inc. revealed significant violations. The firm was producing drug products without valid prescriptions for individually-identified patients, which, under the Federal Food, Drug, and Cosmetic Act (the Act) and the subsequent Compounding Quality Act (CQA), means these drugs are not exempt from statutory requirements. Consequently, these products are considered unapproved new drugs and misbranded drugs, violating Sections 505(a) and 502(f)(1) of the Act.

Furthermore, serious deficiencies in sterile drug production practices were observed, rendering all sterile products adulterated under Section 501(a)(2)(A) of the Act. These deficiencies included technicians wearing non-sterile attire and having exposed skin during aseptic processing, an unsuitable ISO 5 area with unsealed ceiling panels and lacking HEPA filters, and an inadequate design for hoods that compromised unidirectional airflow. The firm also labeled products with unestablished expiration dates (up to 180 days).

Because Medaus, Inc. manufactured and distributed drugs without individual patient prescriptions, their operations are subject to FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR 210 and 211). Significant CGMP violations were noted, including failure to: ensure expiration dates were supported by stability testing, maintain equipment for aseptic conditions, ensure appropriate personnel