FDA 483 - North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - August 25, 2025

An FDA inspection conducted at North American Custom Laboratories, LLC, operating as FarmaKeio Superior Custom Compounding, from August 25 to September 5, 2025, revealed significant concerns regarding the sanitation of its drug production areas. The inspection, documented in an FDA Form 483, cited issues indicating that drug products might have been prepared under insanitary conditions.A primary observation highlighted that production environments contained surfaces difficult to clean, porous, or visibly compromised. Specifically, within an ISO 7 classified buffer room, around an ISO 5 laminar flow hood used for non-hazardous sterile compounding, inspectors noted chipped paint around a HEPA filter, peeling paint on the ceiling tile, and a gap in the wall paneling. These structural defects, present for at least a month, compromise the sterile environment necessary for drug manufacturing. During this period, numerous lots of sterile compounded drug products, including Pyridoxine Hydrochloride/Tirzepatide injection, were prepared in this affected area and subsequently distributed to patients.These observations, issued under FD&C Act Section 704(b), underscore the firm"s non-compliance with maintaining appropriate manufacturing controls. FarmaKeio Superior Custom Compounding is required to address these findings by developing and implementing corrective actions to ensure the safety and quality of its sterile and non-sterile drug products. The company must provide a formal response detailing its plan to rectify these critical deficiencies.