# FDA WARNING_LETTER - mongiello italian cheese specialties, inc.  - August 13, 2013

Source: https://www.keypedia.com/records/warning_letter/mongiello-italian-cheese-specialties-inc/826665cc-c2ee-4fed-a320-957e10b41d12

> FDA WARNING_LETTER for mongiello italian cheese specialties, inc.  on August 13, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: mongiello italian cheese specialties, inc. 
- Inspection Date: 2013-08-13
- Product Type: Food
- Office Name: New York District Office
- Summary: The FDA conducted an inspection of Mongiello Italian Cheese Specialties, Inc. (Formaggio) in July and August 2013, following USDA FSIS notifications of *Listeria monocytogenes* in finished products and environmental samples. The inspection revealed significant insanitary conditions violating FDA's Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 110. Environmental swabs collected by FDA also confirmed *L. monocytogenes* presence, and PFGE analysis showed these strains were indistinguishable from USDA samples, indicating widespread contamination and established niche areas. This renders the firm's cheese adulterated under 21 U.S.C. § 342(a)(4).

Key violations included: failure to prevent drip/condensate contamination (21 CFR § 110.20(b)(4)); inadequate protection against contamination from foreign substances like sleeve arms contacting food (21 CFR § 110.10(b)(9)); employees not sanitizing hands thoroughly (21 CFR § 110.10(b)(3)); inadequate sanitary plumbing (21 CFR §110.37(b)(3)); and insufficient pest protection (21 CFR § 110.20(b)(7)). The letter highlights the serious public health concern of *L. monocytogenes*. The firm must respond within 15 working days with specific corrective actions and prevention plans. Failure to comply could result in product seizure, injunction, and reinspection fees.

## Related Officers

- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/mongiello-italian-cheese-specialties-inc/d13d70e8-a606-44cc-b3ad-f8f25dc26cc9

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d