FDA WARNING_LETTER - Rolf's Patisserie - February 23, 2011

An FDA inspection of Rolfs Patisserie, conducted from December 23, 2010, to February 23, 2011, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Environmental swabs confirmed the widespread presence of enterotoxigenic Staphylococcus aureus (S. aureus) in the facility, including on food-contact surfaces and in raw material topping, indicating insanitary conditions. Consequently, the food products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations included the firm's failure to effectively clean and sanitize equipment to prevent contamination (21 CFR 110.35(a)), as evidenced by repeat S. aureus findings. Additionally, the firm failed to properly hold foods capable of supporting rapid microbial growth, such as leaving dairy-containing pastry cream at room temperature for extended periods (21 CFR 110.80(b)(3)). While the firm submitted corrective actions, FDA deemed them inadequate regarding the effectiveness of cleaning and sanitizing. Rolfs Patisserie must re-evaluate its cleaning operations, provide documentation of corrections, and ensure continuous control of microbial contamination. The firm is required to respond within fifteen working days, detailing corrective actions and a timetable to prevent recurrence, or face potential regulatory actions like seizure or injunction.