Ballard Plaza Pharmacy I, Inc. – FDA Warning Letter, May 17, 2016

An FDA inspection of Ballard Plaza Pharmacy I, Inc. from April 25 to May 17, 2016, revealed significant deficiencies in its drug production practices. The firm produced drug products that failed to meet the conditions of section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for a portion of its compounded products. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

Furthermore, the inspection identified serious insanitary conditions, causing drug products intended to be sterile to be adulterated under section 501(a)(2)(A) of the FDCA. Observations included detached wood paneling in an ISO 5 Laminar Flow Hood, poor aseptic practices (e.g., operator's non-sterile lab coat contacting the work surface), use of non-sterile wipes, and failure to demonstrate adequate ISO 5 area performance through studies. The ineligible compounded products were also deemed misbranded under section 502(f)(1) of the FDCA because their labeling lacked adequate directions for use, as they are not amenable to self-diagnosis.

While the firm submitted a response on June 2, 2016, some proposed corrective actions lacked supporting documentation, and no interim actions or revised procedures were provided. FDA strongly recommends a comprehensive assessment of operations, potentially with a third-party consultant. The firm must promptly correct all violations and respond within fifteen working days, detailing corrective steps and preventing recurrence, or face potential legal action.