Recipient NameMr. Michael O’Neill
- Kerry Inc
3400 Millington Road
Beloit, WI 53511
- Issuing Office:
- Chicago District Office
Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
July 26, 2018
VIA UPS DELIVERY
Mr. Michael O’Neill, CEO
3400 Millington Road
Beloit, WI 53511
Dear Mr. O’Neill:
The United States Food & Drug Administration (FDA) inspected your Kerry, Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723 from June 14 to 29, 2018. The inspection was initiated as (b)(4) in three environmental swabs taken from your (b)(4) cereal (“cereal”) production rooms during FDA’s inspection. Further, FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (b)(4).
During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings and the analytical results for the environmental samples collected during the inspection, we determined that the cereal manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We acknowledge you have committed to performing corrective actions both verbally and in a written response dated July 23, 2018, which includes a description of the corrective actions taken by your firm. In your written response, you indicate that you have hired a third-party consultant, conducted a root cause analysis, plan to update your firm’s food safety plan, and have updated the following documents: (b)(4). We will verify the adequacy of the implementation of your corrective actions during the next FDA inspection.
The following are significant violations of the CGMP & PC rule:
1. Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1). The hazard evaluation must include an evaluation of environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen, to comply with 21 CFR § 117.130(c)(1)(ii). After the (b)(4) undergo a lethal treatment in the (b)(4), they are exposed to the environment at multiple steps (e.g., (b)(4)) before the cereal is bagged and sealed. However, your hazard analysis for the cereal (revised and approved February 6, 2018) did not identify contamination of RTE cereal with the environmental pathogen of Salmonella as a food safety hazard requiring a preventive control. Salmonella contamination of RTE cereal from the environment is a known or reasonably foreseeable hazard that should have been identified as a hazard requiring a preventive control because, for example, it has resulted in at (b)(4) salmonellosis in such cereal 1.
Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).
2. You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1). Specifically, because the cereal is an RTE food exposed to your production environment you are required to identify and implement a preventive control for the hazard of contamination of RTE cereal with an environmental pathogen, e.g., Salmonella. However, you did not identify and implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen Salmonella as required by 21 CFR §§ 117.135(a)(1) and (c)(3). The failure of your sanitation controls to significantly minimize or prevent the environmental hazard of Salmonella is reflected in three FDA environmental samples that were positive for the same strain of Salmonella (b)(4). These samples were collected from the bottom of the roll-up door between your cereal coating room and your processing room for rice crisps intended for pet food, the leg in Line (b)(4), and from the yellow plastic on the roll-up door between Line (b)(4) warehouse space #1 and the northeast entry into the cereal coating room. The failure is further evidenced by your 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples between September 29, 2016 and May 16, 2018.
3. You did not implement written corrective action procedures that must be taken if preventive controls are not properly implemented to comply with 21 CFR 117.150(a)(1) and (d). Specifically,
a) You did not implement your sanitation corrective action procedure, (b)(4). Section 4.1 of this procedure defines corrective actions as “steps taken to remove the root cause(s) of an existing nonconformity or undesirable situation.” Section 5.1.9 requires that a “Corrective Action/Preventive Action (CAPA) must be determined” for “any other significant event effecting food safety or quality.” Further, section 5.4 requires that “[t]he root cause analysis (RCA) must be thoroughly documented,” and section 5.5 requires that “[a]ll corrective . . . actions must be thoroughly documented and based on the results of the RCA.” However, you did not conduct and document a root cause analysis for the persistent findings of Salmonella in your facility during the time period of September 29, 2016 to May 16, 2018.
b) You did not fully implement your sanitation corrective action procedure as specified in (b)(4). Section 18.104.22.168 require that after a positive pathogen result in zones 2, 3, or 4, “[a] response team must be formed to assess the result with the goal of defining a root cause and corrective action.” Your facility completed an “Environmental Investigation Report” for each positive pathogen sample you found; however, there is no documentation that you formed a response team to determine the root cause and corrective actions necessary to prevent the routine reoccurrence of Salmonella throughout your facility during the time period of September 29, 2016 to May 16, 2018.
4. You did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required by 21 CFR 117.165(a). Specifically, you did not fully implement your Kerry North America Corporate Procedure- Environmental Monitoring Procedure SOP No# 0140.001 (Version No: 002) and Kerry Gridley, IL (b)(4) Environmental Monitoring Procedure SOP# 0140.001.001 (Approval Date 6/5/2013). Table 1 of SOP No# 0140.001 and section 5.0 of SOP# 0140.001.001 require (b)(4) zone 2 microbiological tests. However, from September 29, 2016 to June 29, 2018, you did not swab Zone 2 locations for environmental pathogens in your (b)(4) room and packaging room for cereal where RTE food is exposed to the environment.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Lauren Crivellone, Compliance Officer, 550 W. Jackson Boulevard, Suite 1500, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Lauren Crivellone at 312-596-4157 or firstname.lastname@example.org.
William R. Weissinger, MS
Chicago District Director
Division of Human and Animal Food
Operations Division 6 East