IF Holding II, LLC dba Initiative Foods – FDA Warning Letter, Apr 9, 2026

IF Co-Pack, LLC, doing business as Initiative Foods, received a formal warning from the FDA following an inspection of its Sanger, California facility conducted between March 31 and April 9, 2026. The inspection focused on the company"s manufacturing of ready-to-eat baby food products, specifically fruit and vegetable pouches. The FDA identified significant violations of the Hazard Analysis and Risk-Based Preventive Controls regulation (21 CFR Part 117), which requires food producers to identify and manage safety risks. The primary issue involved the company"s failure to recognize patulin—a toxin produced by mold in fruits—as a hazard requiring preventive controls. Despite a previous voluntary recall in February 2026 due to elevated patulin levels, the firm had not established strict specifications or documentation processes for testing incoming fruit ingredients. The FDA noted that the company used ingredients without verifying toxin levels and lacked a formal system to review safety certificates from suppliers. Initiative Foods is required to respond in writing within 15 working days, detailing the specific corrective actions taken to address these deficiencies and prevent their recurrence. Failure to comply may result in legal action, including product seizures or manufacturing injunctions.