It is FDA's practice to issue Warning Letters in order to
provide individuals and companies an opportunity to take voluntary
and prompt corrective action before it initiates an enforcement
action. The agency's position is that it issues Warning Letters
only for violations of regulatory significance. Significant
violations are those violations that may lead to enforcement action
if not promptly and adequately corrected.
A Warning Letter is the agency's principal means of
achieving prompt voluntary compliance with the Federal Food, Drug,
and Cosmetic Act ("the Act"). Below is a brief synopsis
of recent food-related Warning Letters.
On July 22, 2013, the FDA issued a Warning Letter to Mark
Palmer, President of Ocean Beauty Seafoods, LLC, a manufacturing
facility located in Seattle, Washington. During an inspection, the
agency observed serious violations of the seafood Hazard Analysis
and Critical Control Point (HACCP) regulation (21 CFR 123), and the
Current Good Manufacturing Practice (CGMP) regulation for foods.
(21 CFR 123 & 110). Because the facility failed to have a HACCP
plan in place, its fish and fishery products were rendered
adulterated within the meaning of Section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the Act), 21 USC. § 342(a)(4).
The agency also took samples that tested positive for Listeria
monocytogenes. Accordingly, the company's hot and cold smoked
salmon products were deemed adulterated, in that they were
prepared, packed, or held under insanitary conditions whereby it
may have been rendered injurious to health.
On July 15, 2013, the FDA issued a Warning Letter to Steve
Ellenberger, Owner and CEO of The Bagel Works Café, Inc., a
manufacturing facility located in Kansas City, Kansas. During an
inspection, the agency observed serious violations of the CGMP
regulations in Part 110 (21 CFR 110). These violations caused the
foods manufactured at the facility to be adulterated within the
meaning of section 402(a)(4) of the Act [21 USC §342(a)(4)] in
that they were prepared, packed, or held under insanitary
conditions whereby they may have been contaminated with filth or
rendered injurious to health. The company had a prior inspection in
May 2013 and the July inspection revealed the same or similar
conditions as the earlier inspection. The facility failed to take
effective measures to exclude pests from processing areas, to
protect food from contamination, to maintain equipment and finished
food in an acceptable condition, and to maintain the physical
facilities in a sanitary condition.
On July 12, 2013, the FDA issued a Warning Letter to Roy S
Tucillo, Sr, President of Advanced Foods, Inc., a seafood
establishment located in Westbury, New York. During an inspection,
the agency observed serious violations of the seafood HACCP
regulation, violating the specific requirements for imported fish
and fishery products, as set forth in 21 CFR 123.12. The
establishment needed to implement written verification procedures
that included product specifications and an affirmative step(s) for
ensuring that the fish and fishery products that it imports into
the United States were processed in accordance with the seafood
HACCP regulation. However, the agency found that the establishment
had no written verification procedures and did not implement an
affirmative step for fishery products that it imported.
On July 11, 2013, the FDA issued a Warning Letter to Michelle
L. Myrter, President & Co-Owner of Castle Cheese, Inc., a food
facility located in Slippery Rock, PA. During an inspection, agency
investigators obtained product labeling and manufacturing records
for several cheese products and found violations of the food
labeling regulations, 21 CFR Part 101, that caused the
company's International Packing Parmesan Cheese, Romano 100%
Grated Cheese, and 100% Grated Parmesan Cheese products to be
misbranded within the meaning of section 403 of the Act [21 USC
§ 343]. Specifically, the company omitted valuable
constituent, substituted varieties of cheeses for those declared on
the products' labels, failed to use the common name of each
ingredient, and contained ingredients not permitted by the
standards prescribed by regulation. Additionally, these products
were deemed to be adulterated within the meaning of sections
402(b)(1), 402(b)(2), and 402(b)(4) of the Act [21 USC §
342(b)(1), 342(b)(2) and 342(b)(4)].
The companies had fifteen days to respond to the agency in
writing to explain the steps taken to correct the violations. FDA
will evaluate the responses and can take regulatory action without
further notice, such as seizure, injunction, or the initiation of
administrative enforcement procedures.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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