FDA WARNING_LETTER - Vaccaro's Italian Pastry Shop, Inc. - March 01, 2019

The FDA inspected a bakery facility in Baltimore, MD, from December 7, 2018, to March 1, 2019, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117). The facility's Ready-to-Eat (RTE) bakery products were deemed adulterated due to insanitary conditions.

Key violations include: - **No Food Safety Plan:** Failure to prepare and implement a food safety plan for products like macaroons, cookies, and cakes (21 CFR § 117.126(a)(1)). - **Inadequate Hazard Analysis:** No hazard analysis conducted for allergen cross-contact, vegetative pathogens (e.g., *E. coli*, *Salmonella* from wheat flour/tree nuts), or mycotoxins. Environmental pathogens like *Listeria monocytogenes* and *Salmonella* were not evaluated (21 CFR § 117.130(a), (c)(1)(ii)). - **Lack of Preventive Controls:** Failure to identify and implement preventive controls, monitoring procedures, corrective action procedures, or verification activities (21 CFR § 117.135(a), §§ 117.140-117.165). - **Poor Sanitation:** Non-food contact surfaces were