FDA WARNING_LETTER - MasterPharm LLC - June 15, 2020

On July 19, 2021, the FDA issued a Warning Letter to MasterPharm LLC following an inspection from May 28 to June 15, 2020, which revealed serious deficiencies in drug product production. The firm voluntarily ceased dispensing capsule dosage forms and recalled compounded products due to cross-contamination, super-potency, and lack of processing controls.

The FDA found Finasteride Plus capsules adulterated and misbranded. Analysis showed the capsules contained an average of 1.49 mg of finasteride, exceeding the labeled 1.25 mg, and undeclared minoxidil at 127.86 mg per capsule, greatly exceeding amounts in FDA-approved products. This violates FDCA sections 501(c) and 502(a).

Additionally, drug products were prepared, packed, or held under insanitary conditions, violating FDCA section 501(a)(2)(A). Observed issues included visibly dirty equipment in ISO classified aseptic processing areas, non-microbial contamination, inadequate containment for hazardous drugs, and insufficient smoke studies under dynamic conditions. Gloved fingertip sampling was improperly conducted, and the facility design allowed lesser quality air into higher quality areas.

While MasterPharm's responses to the Form FDA 483 included some adequate corrective actions, others lacked sufficient information or supporting documentation, such as comprehensive smoke study data and proof of pressure gauge installation