Attorney Marc C. Sanchez blogged recently about a list of the top observations made by the Food and Drug Administration (FDA) during an inspection. The list, provided below, is a snapshot of the most common violations of the Food Drug and Cosmetic Act's governing regulations. The observations are part of the Form 483 cited to facilities after an inspection and a precursor to the dreaded Warning Letter. Facilities subject to FDA should take heed, if for no other reason, because the number of inspections is dramatically increasing. The FDA issued 10,000 Form 483s in 2011. This was a new record; a record likely to be broken again this year.

Preparation and a proper understanding of the regulations is the best bet to ward off an inspection. The top lists provide a starting point to understand where regulations have changed or where the FDA’s focus has shifted. A few things top the lists annually. This is usually the result of overlooking regulations, which is usually due to an environment where regulatory compliance chases behind operations. As you review the lists, reflect on your own operations or the companies you audit. Before the FDA arrives, be prepared by addressing the top observations from 2011 and by correcting the underlying environment that created those deficiencies.

Marc C. Sanchez
FDA/USDA Food Attorney
Originally posted on www.foodct.com

21 CFR 110.35(c) – Effective measures are not being taken to exclude pests from the processing areas/protect against the contamination of food on the premises by pests;
21 CFR 123.11(b) – Not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice/ condition and cleanliness of food contact surfaces/ prevention of cross-contamination from insanitary objects/ maintenance of hand washing, hand sanitizing, and toilet facilities/ protection of food, food packaging material, and food contact surfaces from adulteration/ proper labeling, storage and use of toxic chemicals/ control of employee health conditions/ exclusion of pests.

21 CFR 123.6(b) – Did not implement the monitoring/ record keeping/ verification procedures listed in your HACCP plan;
21 CFR 123.11(c) – Not maintaining sanitation control records that document monitoring/ corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice/ condition and cleanliness of food contact surfaces/ prevention of cross-contamination from insanitary objects/ maintenance of hand washing, hand sanitizing, and toilet facilities/ protection of food, food packaging material, and food contact surfaces from adulteration/ proper labeling storage and use of toxic chemicals/ control of employee health conditions;
21 CFR 123.6(b) – No written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur;
21 CFR 110.2(b)(7) – Failure to provide adequate screening or other protection against pests;
21 CFR 110.20(b)(4) – The plant is not constructed in such a manner as to allow floors/walls/ceilings to be adequately cleaned and kept clean/kept in good repair; 21 CFR 110.35(a) Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition;
21 CFR 123.6(c)(3) – HACCP plan does not list a critical limit that ensures control of one or more hazards/ lists a critical limit that does not ensure control of one or more hazards.

USDA SuperTracker.
Just in time to help Americans keep their New Year's resolutions by making healthy food and physical activity choices the US Department of Agriculture announced the introduction of a new nutrition SuperTracker.

Described as a “comprehensive, state-of-the-art resource,” the USDA says that SuperTracker will be available at ChooseMyPlate.gov, and will help individuals “as they make changes in their life to reduce their risk of chronic disease and maintain a healthy weight.” The web tool also is timed to pair up with the department’s latest consumer eating message, “Enjoy your food, but eat less.” A free, on-line tool, SuperTracker is designed to allow consumers the ability to get a personalized recommendation of how much to eat and exercise, track eating and physical activity and measure progress. Customizable features include goal setting, virtual coaching, weight tracking and journaling.

Source: wwwaibonline.org