Hans Kissle Company LLC and Harold Brey & Sons Inc. are the latest food companies to receive warning letters from the U.S. Food and Drug Administration. Hans Kissie is in Haverhill, MA, and Harold Brey & Sons are in Jeffersonville, NY.

The Hans Kissle ready-to-eat (RTE) salads and prepared foods manufacturing facility at 9 Creek Brook Drive, Haverhill, MA, was inspected by FDA from March 9 through April 5, 2019. In its warning letter, FDA said:

“During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule…” the FDA warning letter says. “

Additionally, the FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections.”

Based on its inspectional findings and the analytical results for the environmental samples, the FDA found the RTE foods manufactured in Massachusetts are adulterated. FDA found a failure “of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule…”

Owners of Harold Brey & Sons Inc. were reminded in their warning letter that the “processing plant where eggs are cleaned and packaged, at 607 Swiss Hill Road, Jeffersonville, NY, (was inspected) from May 21 through May 29, 2019.”

During the inspection, the investigators observed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation. FDA found violations of the  Production, Storage, and Transportation regulation (the shell egg regulation) that render the company’s shell eggs to be adulterated because they “may have become contaminated with filth, or whereby they may have been rendered injurious to health.”

Harold Brey & Sons Inc. responded to FDA’s inspection observations, but the agency was not fully satisfied.

Among the significant violations was the failure to conduct environmental testing, implement a SE prevention plan, or take adequate corrective actions.

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