FDA warning letter · Drugs

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Issued Nov 18, 2022 · Posted by FDA Jan 24, 2023

FDA published a close-out letter on Mar 20, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Your firm did not adequately disinfect materials or supplies during transfer from the ISO 8 cleanroom into higher classification areas.

Passage 2
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.