MasterPharm LLC — FDA Warning Letter Findings

Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.

In your response, you stated: “we are currently in the process of making necessary changes to the ISO7 hazardous negative pressure room to add a pressure gauge to measure the pressure differential between the Clean Room (b)(4) , which houses the BSC/ (b)(4) , and (b)(4) .” You also provided a purchase order for the gauge. However, it is unclear if the pressure gauge has been installed because you did not provide updated information such as the installation date and/or a photo of the installed gauge. Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A. FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation. D.

The ISO classified aseptic processing areas have difficult to clean and visibly dirty equipment and surfaces.

Non-microbial contamination was observed in your production area.

Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area. Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for…

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Gloved fingertip sampling was conducted immediately after an operator disinfected their gloved hands. Therefore, these results may not provide meaningful data.

In your response, you stated: "All smoke studies are performed dynamically with MasterPharm's operators performing Aseptic Process Simulation (b)(4) and observed by supervisory staff from MasterPharm." However, a review of smoke study videos, dated March 26th, 2020, collected during the inspection found that the smoke studies did not include all processing steps performed and equipment used within ISO 5 areas during aseptic drug production. The March 2020 smoke studies only evaluated air flow patterns for (b)(4) of vials and syringes. Other aseptic processing steps your firm performs in the ISO 5 areas, including but not limited to, use of mechanical pumps, transfer of materials, and vial stoppering were not simulated in the smoke study videos. Furthermore, your response did not include documentation of any new smoke studies conducted since March 2020.