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

Source: https://www.keypedia.com/records/warning_letter/vaccaros-italian-pastry-shop-inc/6e8eb946-efd9-4c79-9825-346b42a87c27

> FDA WARNING_LETTER for Vaccaro's Italian Pastry Shop, Inc. on March 01, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vaccaro's Italian Pastry Shop, Inc.
- Inspection Date: 2019-03-01
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)

Company: https://www.keypedia.com/companies/vaccaros-italian-pastry-shop-inc/d6f25c9c-4370-42c3-803d-c02d00366c74

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e