North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
FDA issued a warning letter to North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding (Richardson, TX) following a March 2022 inspection that identified serious insanitary conditions in sterile drug compounding operations. Violations included inadequate sterilization equipment, insufficient disinfection procedures, improper handling of hazardous drugs, failed smoke studies, and inadequate media fills — all causing drug products to be adulterated under section 501(a)(2)(A) of the FDCA. The firm had already initiated a voluntary recall of sterile drug products in April 2022. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Required actions (3)
FDA acknowledges that your firm initiated a voluntary recall of drug products that are intended to be sterile on April 5, 2022.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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