FDA WARNING_LETTER - Medoz Pharmacy of Polk Inc - August 09, 2019

On September 25, 2020, the FDA issued a Warning Letter to Medoz Pharmacy of Polk Inc. following an inspection from July 30 to August 9, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under Section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Observed violations included: - Presence of vermin (dead ants, living spiders, dead cockroach) in the cleanroom, anteroom, and non-sterile suite. - Inadequate containment, segregation, and cleaning for hazardous drug products, risking cross-contamination. - Visibly dirty equipment and surfaces, including blue stains on an ISO 5 work surface during aseptic production. - Cracks in the cleanroom flooring. - Improper gowning procedures by personnel, including bare hand exposure in the ISO 5 area. - Manual contact with inner surfaces of sterile stoppers during aseptic production. - Stained HEPA filters, gaps, and chipping paint around HEPA frames in cleanrooms. - Failure to use a sporicidal agent in ISO 5 areas. - Inadequate smoke studies under dynamic conditions to demonstrate unidirectional airflow in the ISO 5 area.

The firm stated it ceased sterile compounding and voluntarily relinquished its Florida Department of Health sterile compounding permit effective August 2, 2019. The FDA recommends