Empower Clinic Services, LLC dba Empower Pharmacy — FDA Warning Letter Findings

Your firm failed to appropriately sterilize equipment located in the ISO 5 area. Specifically, your firm did not sterilize the stopper sorting bowl, supply hopper, and insertion station that come into contact with stoppers used in the production of injectable drug products. 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 sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have reviewed your firm’s responses to the Form FDA 483. Regarding your response related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation…

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.

We reviewed your (b)(4) validation for sterilizing the stopper sorting bowl, supply hopper, and insertion station and acknowledge your process improvements. In your response you stated that, “Empower has also implemented a (b)(4) schedule for the stopper sorting bowl and associated components to improve sterility assurance while awaiting additional spare parts.” It is unclear how you determined the adequacy of “a (b)(4) schedule” to ensure the equipment remains sterile. We…

Your firm failed to perform adequate routine environmental monitoring. Specifically, your cleanroom certification consists of nonviable airborne particulate and viable airborne particulate sampling of locations surrounding your (b)(4) filling line, but does not include sampling within the critical area where aseptic processing occurs.

Regarding your certification of your ISO-5 filling room (Room 1267), your response makes reference to sampling in accordance with ISO standard 14644-1:2015. However, we note that the nonviable particulate sampling conducted during your April 2024 and October 2024 certifications did not conform to this standard in that the sampling locations did not appear to be divided across the whole cleanroom and did not appear to be of equal area. In addition, ISO standard 14644-1:2015…

Regarding your media fills, we acknowledge your commitments to expand your media fill batch sizes and strengthen your personnel qualification as well as revise your existing procedures. However, it is unclear when you plan to conduct media fills within your ISO 5 filling machine in Room 1267 as you did not provide completed media fills according to the recent changes outlined in Protocol – B&S Process Verification Media Fill.