Tuesday 20 February 2018

Top Food Observations in 2011 (Citations made in Form 483s)

Yesterday Food Court reported on the top ten observations made during a facility audit. Observations are the citations made in a Form 483 Insectional Observation, which can result in a Warning Letter. Upon request the Atlanta Regional Office’s Director of Compliance provided Food Court the top observations made in food. They are:

  1. 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;
  2. 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 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 toliet 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.
  3. 21 CFR 123.6(b) – Did not implement the monitoring/ record keeping/ verification procedures listed in your HACCP plan;
  4. 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;
  5. 21 CFR 123.6(b) – No written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur;
  6. 21 CFR 110.2(b)(7) – Failure to provide adequate screening or other protection against pests;
  7. 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; and
  8. 21 CFR 110.35(a) Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition;
  9. 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.

As the new year begins it is important to ensure that any all SOPs and quality systems are up to date. Hiring an outside consultant at this stage, who can preventatively ensure that the most common errors are avoided, can help save a firm money in responding to a Form 483 or Warning Letter.

A list of the top 10 Drug observations is also available by e-mail request.

Be Sociable, Share!

Leave a comment

Send comment »

Powered by WordPress. Genius Design by MCS.