FDA WARNING_LETTER - Peggy Lawton Kitchens, Inc. - June 12, 2019

The FDA inspected a facility manufacturing Ready-to-Eat (RTE) cookies and brownies from May 28 to June 12, 2019, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). These deficiencies render the RTE products adulterated. Key violations include the firm's failure to implement a food safety plan and written hazard analysis (21 CFR § 117.126, § 117.130). Numerous CGMP issues were cited: inadequately designed and maintained equipment (21 CFR 117.40(a)(1)), insufficient cleaning of food-contact and non-food-contact surfaces (21 CFR 117.35(d), 117.35(e)), and improper cleaning/sanitizing methods and agents (21 CFR 117.35(a), 117.35(b)(1)). Further problems included plumbing lacking backflow prevention (21 CFR 117.37(b)(5)), deficient hand-washing facilities (21 CFR 117.37(e)), and significant employee hygiene failures (21 CFR 117.10(b)(1), 117.10(b)(3)). The firm also failed to minimize allergen cross-contact (21 CFR 117.80(c)(2)), improperly stored raw materials (21 CFR 117.80(b)(7)), and maintained facilities in disrepair with poor sanitation (21 CFR 117.35(a)). Records for employee food safety training were absent (21 CFR 117.4). The firm's June 21, 2019, response was deemed inadequate, lacking sufficient detail or documentation. The company must provide a comprehensive written response within fifteen working days detailing specific corrections, supporting documentation, and timelines to prevent recurrence, or face potential re-inspection fees.