# FDA WARNING_LETTER - Banks Square Market Corp dba The Produce Connection - March 21, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/banks-square-market-corp-dba-the-produce-connection/1ef4e00a-ac68-4a68-8514-8c1a06f09139

> FDA WARNING_LETTER for Banks Square Market Corp dba The Produce Connection on March 21, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Banks Square Market Corp dba The Produce Connection
- Inspection Date: 2022-03-21
- Product Type: Food
- Office Name: Office of Human and Animal Food Operations East – Division 1
- Summary: The FDA inspected a ready-to-eat (RTE) fresh-cut fruit and vegetable processing facility in Wakefield, MA, from February 8 to March 21, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117).

Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes), a human pathogen, in eight of fifty-six swabs, including three from food-contact surfaces. Whole genome sequencing (WGS) identified three strains of *L. monocytogenes*, with two strains genetically identical to clinical isolates from 2019, indicating their capability to cause human illness. Non-pathogenic *Listeria* species were also found, indicating conditions suitable for *L. monocytogenes* growth. These findings led the FDA to determine that the RTE products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)].

The facility failed to identify and implement adequate preventive controls, specifically sanitation controls, to significantly minimize or prevent environmental pathogens like *L. monocytogenes*, as required by 21 CFR § 117.135(a)(1) and (

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/banks-square-market-corp-dba-the-produce-connection/0e229d4b-21e8-4874-975d-433f6ca5ec7d

Office: https://www.globalkeysolutions.net/offices/office-of-human-and-animal-food-operations-east-division-1/d0bca745-2ece-476c-b957-ff51f011aca1