Businesses have 15 days to respond in writing to the FDA after receiving a warning letter. If they don’t correct the violations, the
FDA can take action up to and including shutting down operations.Almark
Foods Inc.’s hard boiled egg processing facility in Gainesville, GA, was
inspected by the FDA from Feb. 5 through 13, and the results determined
that the firm’s food products are adulterated in that they were
prepared, packed, or held under insanitary conditions whereby they may
have been rendered injurious to health. Specifically, lab tests showed
the plant was harboring the pathogen Listeria monocytogenes, and the FDA
noted significant violations of the CGMP & PC Rule.
“L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility
from raw materials, humans, or equipment. Without proper controls, it
can proliferate in food processing facilities where it may contaminate
food.
”Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive and take such
corrective actions as necessary to eradicate the organism. Consuming
foods contaminated with L. monocytogenes can lead to severe, sometimes
life-threatening illness called listeriosis, a foodborne illness, which
is a major public health concern due to the severity of the disease, its
high case-fatality rate, its long incubation time, and its tendency to
affect individuals with underlying conditions,” the FDA warned.According
to the warning letter, Whole Genome Sequencing analysis of an
environmental sample collected on Feb. 6, confirmed that two
environmental swabs were positive for L. monocytogenes.
“One environmental swab was collected from a peeling room floor drain,” and, “One environmental swab was collected from the egg counter
entrance and stainless-steel area at the end of the conveyor belt,”
which is a food contact surface.
FDA officials encouraged the firm to review FDA’s draft guidance for industry entitled, “Control of Listeria monocytogenes in Ready-To-Eat
Foods” for assistance in developing a Listeria control plan to help the
firm comply with the CGMP and PCHF requirements.
