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

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 provided their SOP, the FDA is unable to assess their corrective action. The FDA will verify the adequacy of its corrective action and its implementation during a future inspection.

3. The firm did not handle work-in-process and rework in such a way that it is protected against contamination and the growth of undesirable microorganisms. Specifically,

• Investigators observed employees handling individually shrink-wrapped, irradiated pig ear pet treats during the examination and labeling process. Pig ears that were found to have broken packaging were placed into a separate box by the employees. Management explained that employees remove the broken packaging and the ears are either distributed as loose bulk pig ears or reshrink-wrapped without being irradiated again.

The firm’s April 5, 2020 response includes a document titled “Rework Procedure”, issued on March 30, 2020. This document includes its policies on how you will authorize and handle the rework of products with damaged packaging. Additionally, they indicated that effective (redacted). However, because there is conflicting information between the response and the document titled “Rework Procedure”, the FDA is unable to assess their corrective action. The FDA will verify the adequacy of its corrective action and its implementation during a future inspection.

4. They did not use cleaning and sanitizing agents that are safe and adequate under the conditions of use. Specifically,

• Investigators observed your employees using (redacted) to perform sanitation operations of food-contact surfaces used during the packing of irradiated pig ear pet treats.

As noted above, your April 5, 2020 response includes their plan for cleaning and sanitation of work stations, dated March 30, 2020. This plan describes cleaning with (redacted), followed by cleaning with (redacted). They have not provided sufficient detail for us to assess your corrective action. The FDA will verify the adequacy of its corrective action and its implementation during a future inspection.

The practices described above are ways in which the pet treats you manufacture could become contaminated by undesirable microorganisms. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated.

The presence of undesirable microorganisms in their pet treats is evidence of the significance of their PCAF regulation violations. On July 11, 2019, FDA collected from a retailer two samples of your individually shrink-wrapped Premium Natural Pig Ears, which subsequently tested positive for Salmonella, an undesirable microorganism. They received these pig ear pet treats from their supplier as loose, bulk pig ears, and they packaged and distributed them into interstate commerce on May 1 and 15, 2019. They recalled these pig ear treats on July 26, 2019, and expanded the recall on July 30, 2019, due to the potential for additional products to be contaminated with Salmonella.

The FDA provided the following comments:

The firm stated during the inspection that they have instituted a sampling and testing program for Salmonella for their finished pig ear pet treats. 

The firm told FDA investigators that you add flavorings to some lots of previously irradiated pig ears with (redacted) prior to sealing the final product packaging. The post-irradiation manipulation of the pig ears (for example, flavoring, sorting, packaging, or repackaging) in an environment where pathogens may be present could cause the recontamination of products prior to packaging. As they prepare their Food Safety Plan, which states that a hazard evaluation must include an evaluation of environmental pathogens whenever an animal food is exposed to the environment prior to packaging and the packaged animal food does not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen.

Their April 5, 2020 response states that their employees will be trained (redacted) on hygiene. As they implement this training, they should be aware of, which state that individuals manufacturing/processing, packing, or holding animal food must receive training in the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene, as appropriate to the animal food, the facility, and the individual’s assigned duties. Records documenting this training must be established and maintained and are subject to FDA review.

The full warning letter can be viewed here.

V-Nine Inc.

Hyattsville, MD

An import company in Maryland is on notice from the FDA for not having FSVPs for a number of imported food products.

In a Sept. 24, 2020, warning letter, the FDA described a June 10 and 29, 2020, Foreign Supplier Verification Program (FSVP) inspection at V-Nine Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Pad thai sauce imported from (redacted)

The firm did not meet the requirements to conduct a hazard analysis for the following products:

•  Jasmine rice imported from (redacted)

The firm did not meet the requirements to evaluate your foreign supplier’s performance. They must approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food and document their approval. They did not document your approval of their foreign supplier of jasmine rice imported from (redacted).

The firm did not meet the requirements to perform foreign supplier verification activities for the foods they import. Specifically, they did not document their determination or performance of appropriate supplier verification activities for the jasmine rice imported from their foreign supplier, (redacted). For their jasmine rice imported from (redacted), while they obtained audit certificates, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted and they did not document their determination of the appropriate supplier verification activity.

The full warning letter can be viewed here.

Aspen Sales Group

Bedminster, NJ

An import company in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Oct. 7 warning letter, the FDA described a May 29 and June 10, 2020, Foreign Supplier Verification Program (FSVP) inspection at Aspen Sales Group.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• Fries imported from their foreign supplier, (redacted), located in (redacted).
• Refined Sugar imported from your foreign supplier, (redacted), located in (redacted).

The full warning letter can be viewed here.

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