FDA WARNING_LETTER - Medaus, Inc. - March 11, 2016

On March 7-11, 2016, the FDA inspected Medaus, Inc. dba Medaus Pharmacy, identifying serious deficiencies in sterile drug production, risking patient safety. A Form FDA 483 was issued on March 11, 2016.

Medaus failed to meet Section 503A of the FDCA conditions for exemption from CGMP, adequate labeling, and FDA approval, specifically by not receiving valid prescriptions for individually-identified patients for a portion of drug products. This rendered their compounded drugs "ineligible drug products," subject to full FDCA requirements.

Violations included adulterated drug products under FDCA Section 501(a)(2)(A) due to insanitary conditions, such as infrequent sporicidal agent use in ISO 5 areas, poor facility design allowing influx of poor quality air (e.g., air return next to HEPA filter), and failure to demonstrate adequate protection of ISO 5 areas.

Significant CGMP violations (21 CFR Parts 210 and 211) were observed, causing ineligible drug products to be adulterated under Section 501(a)(2)(B). These included failure to establish time limits for production phases (21 CFR 211.111), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), lack of written procedures for preventing microbiological