FDA WARNING_LETTER - Medical Center Pharmacy, Inc. - October 13, 2015

From September 28 to October 13, 2015, the FDA inspected Medical Center Pharmacy, Inc., identifying serious deficiencies in sterile drug production. The firm 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 compounded drugs.

Violations included adulterated drug products due to insanitary conditions (e.g., porous surfaces, lack of sporicidal disinfectants, inadequate gowning) and significant CGMP violations. These included failure to establish adequate cleaning/disinfecting systems, validate aseptic processes, monitor environmental conditions, perform final product testing, design facilities to prevent contamination, review discrepancies, and ensure appropriate personnel gowning. The ineligible drug products were also misbranded under Section 502(f)(1) as they lacked adequate directions for use for laypersons.

The firm's responses to the FDA 483 were deemed inadequate, particularly regarding the refusal to implement sporicidal disinfectants, claiming USP <797> compliance. The FDA emphasized that insanitary conditions violate Section 501(a)(2)(A) regardless of 503A exemption status. The FDA recommended a comprehensive assessment of operations, possibly with a third-party consultant. Failure to correct violations may result in legal action. A written response detailing corrective actions is required within fifteen working days.