Vita Pharmacy, LLC dba Talon Pharmacy of Boerne — FDA Warning Letter Findings

Regarding the failure to conduct aseptic process simulation (“media fills”) under the most challenging, stressful conditions, your response indicates you will perform media fills that more closely correlate with the (b)(4) batch sizes. However, your response does not describe in any detail the specific manner in which media fill studies will be performed to ensure they simulate the most challenging, stressful conditions associated with actual drug production activities…

Your firm did not disinfect materials during transfer from the ISO7-classified cleanroom into the ISO5-classified area.

Regarding your response to the failure of personnel to adequately disinfect materials as they are transferred from the ISO7-classified area to the ISO5-classified area, you state staff will be retrained in proper sterile compounding procedures, adding this training will be documented accordingly. However, you did not provide any specific details on the cleaning steps in which staff will be trained. Consequently, there is no assurance the outer packaging of materials and supplies will be adequately and routinely disinfected upon transfer from areas of lower air quality to areas of higher air quality. Lastly, your response does not describe the disposition of the lot of drug product being prepared when the observation was made.

Regarding your response to producing hazardous drug products without adequate controls to prevent cross-contamination, you state you will relocate the BSC to a separate, negatively pressured cleanroom. While moving the BSC to a dedicated, negatively pressured cleanroom may be an effective long-term solution, it fails to address the existing cross-contamination risk as you do not commit to immediately ceasing all hazardous drug production, and you did not provide a time frame by which the relocation of the BSC will be complete. It should be noted that when moved, the BSC and room in which it will be housed, as well as the ISO7 area from which it is removed will need to be qualified and appropriately certified/re-certified prior to operation.

Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility. 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 sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have…

Regarding your response to the presence of an unknown substance on the plastic grille of a HEPA filter in the ISO5-classified area, you note the “dark residue” was cleaned and the “stain” removed. You also state the substance was cultured, and no growth was recovered. However, you failed to determine the identity or source of the substance. Consequently, there’s no assurance the underlying problem has been effectively eliminated. Additionally, you did not describe if/how the HEPA filter was evaluated to ensure it was not adversely impacted by the substance (e.g., no filter integrity/leak testing, and airflow/velocity testing were conducted). Consequently, it is not known whether the environment is suitable for sterile drug production.

Regarding the failure to perform airflow visualization (“smoke”) studies in the ISO5-classified BSC where hazardous drugs, intended to be sterile, are produced, you indicate smoke studies will be performed. However, you do not describe in any detail the manner in which smoke studies will be performed, or how they will be evaluated to determine the adequacy of HEPA-filtered airflow within the BSC. You do not state when the studies will be performed or a time frame by which…

Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO5 area. Specifically, smoke studies have never been performed in your ISO5-classified BSC.

The ISO-classified areas had visibly dirty equipment and difficult to clean surfaces. Specifically, an unknown foreign substance was observed adhered to the plastic grille of a HEPA filter in your ISO5-classified area.

You handled hazardous drug products without providing adequate containment and segregation to prevent cross-contamination in that hazardous drug products are produced in an ISO5-classified biological safety cabinet (BSC), which is located in the same ISO7-classified cleanroom where non-hazardous drug products are produced.