- Delivery Method:
- VIA UPS
- Animal & Veterinary
Food & Beverages
Recipient NameMr. Akiva Boclin
- The Lennox, International, Inc.
930 New Durham Road
Edison, NJ 08817-2241
- Issuing Office:
- Division of Human and Animal Food Operations East II
September 29, 2020
Dear Mr. Boclin:
On February 20, 21, 24, and 26, and March 2, 5, 16, and 20, 2020, the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your facility located at 930 New Durham Road, Edison, New Jersey, 08817-2241. This inspection was a compliance follow-up inspection to assess any corrections made since your Class I recall of pig ear pet treats after FDA samples revealed the presence of Salmonella. Those samples, combined with Centers for Disease Control and Prevention (CDC) illness traceback and epidemiological data, reveal that your firm was involved in a nationwide outbreak of multidrug-resistant Salmonella Cerro, Derby, London, Infantis, Newport, Rissen, and I 4,,12:i:-, which resulted in 154 illnesses, including 35 hospitalizations, in 34 States. Twenty-seven of the 154 illnesses were in children younger than five years. This letter notifies you of the evidence of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our inspection of your operation.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We note that you have submitted written responses to the Form FDA 483, explaining what you have done to address our concerns, and we address your responses below. We encourage you to respond in writing to this letter.
Our inspection found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of Part 507 (located in subparts A, C, D, E, and F of Part 507) is prohibited by section 301(uu) of the FD&C Act [21 U.S.C. § 331(uu)]. Additionally, the criteria and definitions in 21 CFR Part 507 apply in determining whether an animal food is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. See 21 CFR 507.1(a)(1)(ii). The introduction or delivery for introduction into interstate commerce of an adulterated food is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, FDA Investigators noted evidence of violation of these requirements, as follows:
1. You did not have a written food safety plan [21 CFR 507.31(a)]. Your food safety plan must include, among other things, a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at your 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, as required by 21 CFR 507.33.
Your April 5, 2020 response indicates that you have hired a food safety consultant and also included a list of items to be covered by your Food Safety Plan. However, because you have not provided your Food Safety Plan, we are unable to assess your corrective action. We will verify the adequacy of your corrective action during a future inspection.
Current Good Manufacturing Practice (CGMP) Requirements
Your animal food facility is subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, and F. During the inspection of your facility, FDA Investigators noted evidence of violation of these requirements, as follows:
1. You 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 [21 CFR 507.14]. 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, as required by 21 CFR 507.14(b)(2). 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 (b)(4) and repackaging bulk unwrapped rawhide treats and pig ears.
Your April 5, 2020 response includes a document titled “Hygiene Rules”, issued on March 30, 2020. This document includes your policies on handwashing and wearing gloves. It also indicates that employees will be trained (b)(4) on cleanliness, personal hygiene, and ways to prevent contamination of goods in the warehouse. You have also stated you will install handwashing signs and make hand sanitizer and gloves available to employees. We will verify implementation of these corrective actions during a future inspection. Please see the comment below regarding training.
2. You did not clean animal food contact surfaces of equipment as necessary to protect against the contamination of animal food or animal food-packaging materials [21 CFR 507.19(b)]. Specifically,
- You stated at the start of the inspection that you only cleaned the processing tables if they appeared dirty.
During the inspection you stated that you had instructed employees to clean and sanitize work stations in between products and at the end of the day. Also, your April 5, 2020 response includes your plan for cleaning and sanitation of work stations, dated March 30, 2020. You indicated that this plan will be documented in an SOP. However, because you have not provided your SOP, we are unable to assess your corrective action. We will verify the adequacy of your corrective action and its implementation during a future inspection.
3. You did not handle work-in-process and rework in such a way that it is protected against contamination and the growth of undesirable microorganisms [21 CFR 507.25(c)(3)]. 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.
Your April 5, 2020 response includes a document titled “Rework Procedure”, issued on March 30, 2020. This document includes your policies on how you will authorize and handle rework of product with damaged packaging. Additionally, you indicated that effective (b)(4). However, because there is conflicting information between the response and the document titled “Rework Procedure”, we are unable to assess your corrective action. We will verify the adequacy of your corrective action and its implementation during a future inspection.
4. You did not use cleaning and sanitizing agents that are safe and adequate under the conditions of use [21 CFR 507.19(c)]. Specifically,
- Investigators observed your employees using (b)(4) to perform sanitation operations of food-contact surfaces used during packing of irradiated pig ear pet treats.
As noted above, your April 5, 2020 response includes your plan for cleaning and sanitation of work stations, dated March 30, 2020. This plan describes cleaning with (b)(4), followed by cleaning with (b)(4). You have not provided sufficient detail for us to assess your corrective action. We will verify the adequacy of your corrective action and its implementation during a future inspection.
The practices described above are ways in which the pet treats you manufacture could be-come 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 (21 CFR 507.3).
The presence of undesirable microorganisms in your pet treats is evidence of the significance of your 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. You received these pig ear pet treats from your supplier as loose, bulk pig ears, and you packaged and distributed them into interstate commerce on May 1 and 15, 2019. You recalled these pig ear treats on July 26, 2019, and expanded the recall on July 30, 2019, due to the potential for additional product to be contaminated with Salmonella.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence, or the occurrence of other vio-lations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may result in legal action without further notice, including, without limitation, seizure, and injunction.
We also have the following comments:
You stated during the inspection that you have instituted a sampling and testing program for Salmonella for your finished pig ear pet treats. Please be aware, biological hazards are not distributed homogenously throughout a lot. Therefore, sampling and testing is not on its own a good indicator of contamination within a product lot.
You told our Investigator that you add flavorings to some lots of previously irradiated pig ears with (b)(4) 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 product prior to packaging. As you prepare your Food Safety Plan, you should be aware of 21 CFR 507.33(c)(2), 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.
Your April 5, 2020 response states that your employees will be trained (b)(4) on hygiene. As you implement this training, you should be aware of 21 CFR 507.4(b)(2) and (d), 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.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
- Guidance for Industry #235: “Current Good Manufacturing Practice Requirements for Food for Animals”, https://www.fda.gov/media/97464/download
- Draft Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”, https://www.fda.gov/media/110477/download
- Draft Guidance for Industry #246: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program”, https://www.fda.gov/media/113923/download
In addition, we note that your written response, dated June 28, 2020, includes a Foreign Supplier Verification Programs for Food Importers (FSVP) plan developed by your consultant for the pig ear treats imported from your foreign supplier (b)(4), located in (b)(4). The FSVP regulation, Title 21, Code of Federal Regulations, Part 1, Subpart L (21 CFR Part 1, Subpart L) implements section 805 of the FD&C Act [21 U.S.C. § 384a]. Under the FSVP regulation, importers must document their review and assessment be-fore relying on another entity’s hazard analysis (21 CFR 1.504(d)), evaluation of a foreign supplier’s performance (21 CFR 1.505(d)), and determination regarding appropriate foreign supplier verification activities (21 CFR 1.506(d)(3)). However, the page provided to document your review and assessment of the FSVP plan is unsigned, and there is no evidence that you documented your review and assessment of the hazard analysis, foreign supplier performance evaluation, or the results of the verification activities.
If you continue to import FDA-regulated food products, you are required to comply with 21 CFR Part 1, Subpart L. For more information regarding this regulation, see:
- Draft Guidance for Industry: “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals”, https://www.fda.gov/media/118241/download
- For more information regarding specific FSVP records requirements, see this page https://www.fda.gov/media/131229/download
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, or you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent to Compliance Officer Jessica D. Weber at United States Food & Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland, 21215. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at firstname.lastname@example.org.
Lori A. Holmquist
Acting District Director
Acting Program Division Director