FDA Issues 11 Warning Letters in Early December

Since December 1, 2013, the Food and Drug Administration has issued 11 warning letters to various retailers, manufacturers and individuals. The agency defines warning letters as:

Correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.”

On December 2nd, 2013, the FDA issued a warning letter to Ameriderm Laboratories, Ltd., warning them that among other things, they failed to withold each lot of components, drug products containers and closures from use until each lot had been sampled or appropriately examined. As a result, over the counter drug products were found to have microorganisms in them. Although the manufacturer proposed further testing, the agency noted that the issues were a repeat from a June 2011 inspection.

On December 3, 2013, the agency issued a warning letter to Van Erk Dairy LLC, stating that the dairy operation had administered Naxcel to a dairy cow without following proper withdrawal procedures, as well as selling a dairy cow for slaughter that had inappropriately elevated levels of a marker residue for ceftiofur, causing the cow to be adulterated. The angecy noted that their investigation found the dairy operations held animals “under conditions that are so inadequate that medicated animals bearing potententially harmful drug residues are likely to enter the food supply.”

On December 3, 2013, the FDA issued a warning letter to the Burzynski Research Institute, after an inspection under the agency’s Bioresearch Monitoring Program. The FDA alleged that the Institute failed to ensure proper monitoring of investigations, and failed to ensure that investigations are being conducted in accordance with proper protocols. The agency also alleged that the Institute failed to obtain sufficient financial information from a sponsor in order to submit complete and accurate certification or disclosure statements.

On December 4, 2013, the FDA issued a warning letter to Mommy Gina Tuna Resources (MGTR) Inc., stating that the company’s Hazard Analysis and Critical Control Points (HACCP) plan for fish and fishery products had serious deviations from the requirements. Notably the company did not conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and include critical control points.