FDA WARNING_LETTER - Sweet Production Inc. - March 06, 2019

On June 17, 2019, the FDA issued a Warning Letter to Sweet Production, Inc. following an inspection of their bakery in San Carlos, CA, from February 19 to March 6, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117), rendering their food adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include the absence of a written food safety plan, as required by 21 CFR § 117.126. The facility also failed to implement effective pest exclusion measures (21 CFR 117.35(c)), evidenced by insects and rodent excreta in ingredient storage, and fly-like insects in the production area. Food contact surfaces were not cleaned frequently enough to prevent allergen cross-contact and contamination (21 CFR 117.35(d), 117.40(a)(6)), with observations of scarred cutting boards, cracked containers, and improper cleaning between uses for allergen-containing and gluten-free products. Floors were not adequately maintained (21 CFR 117.20(b)(4)), showing standing water and pitting. Employee hygiene practices were deficient (21 CFR 117