PORKER
Well-known member
First, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, we expect a prompt response to our findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action.
Second, the FDA will take responsible steps to speed the issuance of warning letters. I have approved a new policy brought forward by the FDA's Chief Counsel to limit warning letter review to significant legal issues. As a result, most enforcement letters will be able to move forward through a more streamlined process. This approach is consistent with the FDA's longstanding historical practice.
Third, the FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA. When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses.
Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.
Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter.
These five procedural changes will help to ensure that violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.
A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.
At my direction, the FDA is developing a formal warning letter "close-out" process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, we will provide to the firm a "close-out" letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a "close-out" letter.
What started this is drugs found in meat !!!
Submitted by Denise Reynolds RD on Nov 20th, 2009
All about:
Food Safety
The FDA has issued letters of warning to two New York food production operations suspected in violation of adulterated food brought about by misuse of animal medications.
Potsdam-based Adon Farms and Lloyd T. Smith & Sons in Canton are dairy farms, and Francis J. Szarek of Westmoreland, NY runs a veal operation.
The Adon dairy was inspected on April 2 and 9, 2009 and the "Warning Letter" mailed on Aug. 5, 2009. The Smith & Sons dairy was inspected in June 2009, and received the issued letter on September 9, 2009.
FDA says that both dairy farms offered animals for slaughter and sale as food that were held under insanitary conditions that may have rendered it injurious to health if brought into the food supply. Tests by the U.S. Department of Agriculture's Food Safety & Inspection Service (FSIS) showed uncooked edible tissues exceeded the allowable levels for penicillin, an antibiotic used to prevent or destroy an infection in the animal. The FDA was also issued warnings to the dairies for inadequate record-keeping and not following federal instructions for the animal drugs, which requires that the animals be held back from sale until the drug residues clear the animals tissue. The penicillin was also used inappropriately and off-label, and not under the supervision of a veterinarian.
The Szarek veal facility was inspected on April 8 and 10, 2009, and its warning letter" also went out on Sept. 9, 2009. FSIS testing showed 0.134 parts per million of flunixin in the liver tissue of a veal calf sold for slaughter. FDA has not established any tolerance level for residues of flunixin and the presence of the drug in edible tissue means the food is adulterated. Like the dairies, it was charged with using animal drugs for "extra label" purposes without the benefit of a veterinarian and without keeping adequate records.
Flunixin is a non-steroidal anti-inflammatory drug used in animals for muscle pain, to alleviate fevers, and to prevent endotoxemia. It is only registered for use in horses and cattle.
It is estimated that 70% of the antibiotics used in the United States are fed to farm animals for non-therapeutic purposes such as growth promotion and to compensate for unsanitary farming conditions. Medical experts fear that the residue of antibiotics that end up in the food supply contribute to human development of bacterial resistance. Many health organizations, such as the American Medical Association and the American Public Health Association urge for the regulation of antibiotics used for animals designated for slaughter for food.
The farms have 15 working days to respond to FDA.
Second, the FDA will take responsible steps to speed the issuance of warning letters. I have approved a new policy brought forward by the FDA's Chief Counsel to limit warning letter review to significant legal issues. As a result, most enforcement letters will be able to move forward through a more streamlined process. This approach is consistent with the FDA's longstanding historical practice.
Third, the FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA. When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses.
Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.
Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter.
These five procedural changes will help to ensure that violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.
A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.
At my direction, the FDA is developing a formal warning letter "close-out" process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, we will provide to the firm a "close-out" letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a "close-out" letter.
What started this is drugs found in meat !!!
Submitted by Denise Reynolds RD on Nov 20th, 2009
All about:
Food Safety
The FDA has issued letters of warning to two New York food production operations suspected in violation of adulterated food brought about by misuse of animal medications.
Potsdam-based Adon Farms and Lloyd T. Smith & Sons in Canton are dairy farms, and Francis J. Szarek of Westmoreland, NY runs a veal operation.
The Adon dairy was inspected on April 2 and 9, 2009 and the "Warning Letter" mailed on Aug. 5, 2009. The Smith & Sons dairy was inspected in June 2009, and received the issued letter on September 9, 2009.
FDA says that both dairy farms offered animals for slaughter and sale as food that were held under insanitary conditions that may have rendered it injurious to health if brought into the food supply. Tests by the U.S. Department of Agriculture's Food Safety & Inspection Service (FSIS) showed uncooked edible tissues exceeded the allowable levels for penicillin, an antibiotic used to prevent or destroy an infection in the animal. The FDA was also issued warnings to the dairies for inadequate record-keeping and not following federal instructions for the animal drugs, which requires that the animals be held back from sale until the drug residues clear the animals tissue. The penicillin was also used inappropriately and off-label, and not under the supervision of a veterinarian.
The Szarek veal facility was inspected on April 8 and 10, 2009, and its warning letter" also went out on Sept. 9, 2009. FSIS testing showed 0.134 parts per million of flunixin in the liver tissue of a veal calf sold for slaughter. FDA has not established any tolerance level for residues of flunixin and the presence of the drug in edible tissue means the food is adulterated. Like the dairies, it was charged with using animal drugs for "extra label" purposes without the benefit of a veterinarian and without keeping adequate records.
Flunixin is a non-steroidal anti-inflammatory drug used in animals for muscle pain, to alleviate fevers, and to prevent endotoxemia. It is only registered for use in horses and cattle.
It is estimated that 70% of the antibiotics used in the United States are fed to farm animals for non-therapeutic purposes such as growth promotion and to compensate for unsanitary farming conditions. Medical experts fear that the residue of antibiotics that end up in the food supply contribute to human development of bacterial resistance. Many health organizations, such as the American Medical Association and the American Public Health Association urge for the regulation of antibiotics used for animals designated for slaughter for food.
The farms have 15 working days to respond to FDA.
