It is the Food and Drug Administration’s (“FDA”) 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 (“FDCA”).

Companies in receipt of a Warning Letter have 15 days to respond to the agency in writing to explain the steps taken to correct the violations. The FDA evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.
Below is a brief synopsis of recent food-related Warning Letters issued between October 17th and November 14th.

Warning Letters issued to two seafood processing facilities

The FDA issued Warning Letters to two seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain the appropriate “critical limits” which are measured and verified. These would include, for example, temperature control measures that are monitored with calibrated instruments, a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”

The FDA rejected one facility’s argument that its tuna salad processing was not a hazard because it did not exceed the critical limit for time and temperature established by the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition (“Guide”). The agency explained that the Guide is irrelevant as to whether or not a critical control point exists. Rather, a critical control point exists wherever control can be applied “to prevent, eliminate, or reduce a food safety hazard.” The FDA clarified that the Guide provides guidance to facilities, but is not binding on FDA.

FDA inspections at the other facility revealed that it also failed to set a critical limit that was adequate. Inspections further revealed that the facility failed to implement HACCP plans for certain products.

Warning Letter issued to one poultry house facility

The FDA also issued Warning Letters to one poultry house for violations of the Egg Safety Rule. The Egg Safety Rule, codified at 21 C.F.R. 118, requires poultry houses to implement certain measures to prevent contamination by Salmonella Enteritidis (“SE”).

The agency found that one poultry house failed to implement its SE prevention plan. FDA inspections also revealed a number of other violations, including:

  1. failure to clean and disinfect the poultry house;
  2. failure to monitor and control pests;
  3. failure to hold and transport eggs at or below appropriate temperatures; and
  4. packaging eggs under unsanitary conditions.

Warning Letters issued to four food processing facilities

The FDA issued Warning Letters to three food processing facilities for manufacturing adulterated food products in violation of the Current Good Manufacturing Procedures (“CGMP”) for Human Food, and to one food processing facility for misbranding food products in violation of the Federal Food, Drug, and Cosmetic Act.

Violations of the CGMP included: (1) failure to exclude pests from food processing areas; (2) failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination of food; (3) failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces; (4) failure to provide hand washing facilities near food processing areas; and (5) failure to ensure that employees wear hair restraints while working with food products.

Misbranding violations included:

  1. failure to label products as containing artificial coloring or chemical preservatives;
  2. failure to label products as containing major food allergens, such as wheat and soy; and
  3. failure to properly format nutrition labels.

Additionally, analysis of environmental samples taken from the facility warned for misbranding resulted in presumptive positives for Listeria monocytogenes.