North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding — FDA Warning Letter Findings

Your firm did not adequately disinfect materials or supplies during transfer from the ISO 8 cleanroom into higher classification areas.

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.

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. 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 response 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…

In your response to Observation 8 of the Form FDA 483, we acknowledge your firm’s statement that, “ (b)(4) .” However, we cannot fully evaluate your response as you did not provide sufficient supporting documentation, such updated media fill protocol or results. In addition, from review of the evidence collected during the inspection, your October 26, 2021, Environmental Monitoring Report lists your action level for the ISO 5 area as (b)(4) cfu/m 3 for “Air Test” and (b)(4)…

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 to Observation 1 of the Form FDA 483, we acknowledge your firm’s statement that you have regained supply of and resumed use of previously unavailable (b)(4) for “immediate use sterile subcutaneous injectable compounding” at your facility. However, you did not provide sufficient evidence of the corrective actions, such as purchase orders, current batch records (i.e., formula work sheets), or (b)(4) testing procedures for the newly acquired (b)(4) .

Regarding the pink residue on the ceiling, vents, and walls in your production area as described in Observation 5 of the Form FDA 483, you provided your revised SOP, 02-CPCP-12 Non-Sterile Hazardous Compound – Hormone Only and committed to “attempting a deep scrubbing of the room.” It is unclear if this cleaning was attempted and/or effective to remediate this observation or if your revised procedures have prevented reoccurrence.

In your response to Observation 7 of the Form FDA 483, we acknowledge your firm’s statement that, “Moving forward, when smoke studies are conducted, footage from video will record, in detail, the dynamic compounding of sterile compounding in a PEC.” However, we cannot fully evaluate your response as you did not provide sufficient supporting documentation, such as an updated smoke study protocol or an updated detailed report, and/or video.

Your firm used a (b)(4) for the purposes of product sterilization that was not appropriate for pharmaceutical use and the (b)(4) testing was inadequate. Therefore, you do not have assurance that the (b)(4) was integral throughout use.