Companies put of notice for salmonella on pig ear dog treats and foriegn import

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

The Lennox, International, Inc.

Edison, NJ

A pet food company in New Jersey is on notice from the FDA after inspectors found Salmonella on their pig ear dog treats. This warning letter serves as a reminder that raw pet food products can contain dangerous pathogens and should be handled as carefully as other products. Consumers should also beware of cross-contamination from pet food on surfaces and hands.

In a Sept. 29 warning letter, the FDA described a Feb. 20,21,24, and 26 and  March 2, 5, 16, and 20, 2020, and 30 inspections at The Lennox, International, Inc. manufacturing facility. The FDA found that the firm had significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation 

In response, the FDA issued the firm a  Form FDA 483.

The significant violations:

1. The firm did not have a written food safety plan. Their food safety plan must include a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at their facility, to assess the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.

Their April 5, 2020 response indicates that they have hired a food safety consultant and also included a list of items to be covered by your Food Safety Plan. However, because they have not provided their Food Safety Plan, the FDA is unable to assess their corrective action. The FDA will verify the adequacy of its corrective action during a future inspection.

Current Good Manufacturing Practice (CGMP) Requirements

The firm’s animal food facility is subject to the CGMP requirements. During the inspection of their facility, FDA Investigators noted evidence of a violation of these requirements, as follows:

1. The firm did not take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against the contamination of animal food. Methods for conforming to hygienic practices and maintaining cleanliness include washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination. Specifically,

• Investigators observed employees handling pig ear pet treats with ungloved hands during the sorting of unwrapped irradiated pig ear treats, the unwrapping of individually-wrapped irradiated pig ear pet treats, and the repackaging of these treats into 25-count finished product bags or bulk boxes.
• Investigators observed an employee rubbing his nose with his arm and hand while handling rawhide pet treats and other employees pressing rawhide knotted bones to their noses prior to packaging.
• Employees were observed returning from breaks without using hand soap to wash their hands prior to returning to (redacted) and repackaging bulk unwrapped rawhide treats and pig ears.

The firm’s April 5, 2020 response includes a document titled “Hygiene Rules”, issued on March 30, 2020. This document includes its policies on handwashing and wearing gloves. It also indicates that employees will be trained (redacted) on cleanliness, personal hygiene, and ways to prevent contamination of goods in the warehouse. They have also stated they will install handwashing signs and make hand sanitizer and gloves available to employees. The FDA will verify the implementation of these corrective actions during a future inspection. Please see the comment below regarding training.

2. The firm did not clean animal food contact surfaces of equipment as necessary to protect against the contamination of animal food or animal food-packaging materials. Specifically,

• The firm stated at the start of the inspection that they only cleaned the processing tables if they appeared dirty.

During the inspection, they stated that they had instructed employees to clean and sanitize work stations between products, and at the end of the day. Also, their April 5, 2020 response includes their plan for cleaning and sanitation of work stations, dated March 30, 2020. They indicated that this plan will be documented in a Standard Operating Procedure (SOP). However, because they have not…