FDA EIR - Nat2 Inc - December 02, 2022

The FDA conducted a surveillance inspection of Nat2 Inc. (doing business as Nature's One LLC) in Heath, OH, from November 14 to December 2, 2022. This comprehensive inspection focused on powdered infant and toddler formula manufacturing, adhering to current Good Manufacturing Practices (cGMP) regulations. While no formal FDA Form 483 was issued, several significant issues were identified and discussed with company management.

Main observations included the company's reliance on supplier certificates of analysis for infant formula premix nutrient levels instead of conducting their own pre-use testing, and a failure to record the time of activity on cleaning, sanitizing, and maintenance records. Furthermore, Nat2 Inc. lacked documented corrective actions and root cause analyses for positive environmental swab results. Other issues involved observing dead and live insects in the raw materials warehouse, can seam testing records displaying unaddressed out-of-spec values, and the presence of numerous expired raw ingredients. Misleading website content suggesting toddler formula was suitable for infants was also noted.

Nat2 Inc. committed to implementing corrections within 30 days, including establishing pre-use testing for all future premix lots, updating record-keeping to include activity times, enhancing environmental monitoring documentation, addressing can seam record discrepancies, and properly disposing of expired materials. The company also proactively corrected their product lot codes to include a location identifier and removed the problematic website content during the inspection period.