North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding – FDA Warning Letter, Mar 10, 2022

On November 18, 2022, the FDA issued a Warning Letter to North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, following an inspection from March 1 to March 10, 2022. The inspection revealed serious deficiencies in the production of sterile drug products, leading to the issuance of a Form FDA 483 on March 10, 2022. The firm initiated a voluntary recall of sterile drug products on April 5, 2022.

The FDA found that drug products were prepared, packed, or held under insanitary conditions, rendering them adulterated under section 501(a)(2)(A) of the FDCA. Specific violations included: 1. Use of an inappropriate (b)(4) for product sterilization with inadequate testing. 2. Failure to adequately disinfect materials during transfer into higher classification areas. 3. Inadequate containment, segregation, or cleaning for hazardous drug products, risking cross-contamination. 4. Failure to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow in the ISO 5 area. 5. Media fills not performed under challenging conditions, lacking assurance of aseptic production.

The FDA reviewed the firm's March 30, 2022 response but found several corrective actions insufficient due to lack of supporting documentation, such as purchase orders, updated protocols, or video evidence for smoke studies and