FDA WARNING_LETTER - Sunny Creek Farm Inc. - August 20, 2021

The FDA inspected Sunny Creek Farm's sprouting operation from August 10-20, 2021, revealing serious violations of the Produce Safety Regulation (21 CFR Part 112) and the CGMP & PC rule (21 CFR Part 117). The operation is classified as a farm mixed-type facility.

The inspection found alfalfa, broccoli, and clover sprout products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Failure to comply with the PSR is also a prohibited act.

Key violations include: 1. Failure to discontinue use of pathogen-contaminated seed lots and ensure sprouts from those lots did not enter commerce (21 CFR 112.142(b)(1)), and not reporting positive microbial test findings to suppliers (21 CFR 112.142(b)(2)). The firm's SOP also lacked detail on discontinuing seed lot use or notifying suppliers (21 CFR 112.147(c)). 2. Failure to clean and sanitize food contact surfaces before contact with seeds/beans (21 CFR 112.143(b)), with observations of reused bags without sanitization, residue on a sprout spinner lid, and a worn gasket on another spinner. 3. Environmental monitoring plan did not specify sample collection sites (2