Medlife Pharmacy and Compounding, Inc. – FDA Warning Letter, Apr 18, 2018

The FDA issued a Warning Letter to Medlife Pharmacy and Compounding, Inc. following an April 9-18, 2018 inspection, revealing serious deficiencies in drug production. The firm failed to meet section 503A of the FDCA conditions, specifically by not receiving valid prescriptions for individually-identified patients for some compounded drug products. This renders them ineligible for exemptions from CGMP, adequate directions for use, and FDA approval requirements. Consequently, the firm's drug products were found adulterated and misbranded. Adulteration arose from insanitary conditions, including preparing potent drugs without adequate containment or cleaning to prevent cross-contamination, failing to confirm water quality for non-sterile production, and observing a large equipment stain. Significant CGMP violations (21 CFR Parts 210 and 211) included inadequate facility space (21 CFR 211.42(b)), insufficient equipment cleaning (21 CFR 211.67(a)), lack of a stability testing program (21 CFR 211.166(a)), failure to conduct final product testing (21 CFR 211.165(a)), and inadequate process control procedures (21 CFR 211.110(a)). The ineligible drug products were also misbranded under section 502(f)(1) of the FDCA due to inadequate directions for use. While some corrective actions were acknowledged, the FDA requested further documentation on cross-contamination prevention and water quality testing to meet USP standards. A comprehensive assessment by a third-party consultant was strongly recommended. Failure to promptly correct these violations could lead to legal action, including seizure and injunction. The firm was required to respond within fifteen working days detailing corrective steps.