CLOSEOUT LETTER

JBS Souderton, Inc. dba MOPAC MARCS-CMS 574386 — November 18, 2019

Delivery Method:: VIA UPS and Electronic Mail
Product:: Animal & Veterinary
Drugs

Recipient:: Recipient Name

Todd Scherbing; Recipient Title

General Manager; JBS Souderton, Inc. dba MOPAC; 741 Souder Road
Souderton, PA 18964
United States; todd.scherbing@jbssa.com

Issuing Office:: Human & Animal Food Division East II; United States

Dear Mr. Scherbing,

The Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter 574386, dated 4/23/2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

While it appears you have adequately addressed the violations contained in the Warning Letter, the Agency has the following comments regarding your Preventive Controls plan, titled, “JBS MOPAC FOOD SAFETY PLAN FOR PET FOOD/ANIMAL PROTEIN AND FATS/YELLOW GREASE/UCO”.

You should reference the following resources when evaluating your hazard analysis, preventive controls plan, and other related procedures and documents:

• 21 C.F.R. 507, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=507

• Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Guidance for Industry #245 https://www.fda.gov/media/110477/download

• Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program Guidance for Industry #246 https://www.fda.gov/files/animal%20&%20veterinary/published/CVM-GFI--246-Hazard-Analysis-and-Risk-Based-Preventive-Controls-for-Food-for-Animals--Supply-Chain-Program.pdf

The following are the Agency’s comments regarding your Preventive Controls Plan. Overall, the PC plan does not document what information was used to validate preventive controls that require validation in accordance with 21 C.F.R. 507.47. The Agency’s comments specific to your preventive controls are organized below by each preventive control and each section of each preventive control.

Preventive Control 1

Review 21 C.F.R. 507, Subpart E “Supply-Chain Program” to determine the appropriate supply chain activities.

• Parameters
o The parameter being measured is not specifically stated. It references a document, but does not describe what the actual hazard being measured or controlled is.

• Monitoring
o What
 The item being monitored is described as “specific hazards”, but the hazards are not further named or identified.

• Corrective Action
   o This section does not document an appropriate corrective action in the case of a failure by a supplier. When a failure happens, your procedure must document how you 1) intend to correct the problem, 2) how you intend to prevent the problem from happening again, and 3) that you will conduct reassessment of your hazard analysis and preventive controls procedures when appropriate.
    Examples of correcting the problem include, but are not limited to: recalling affected product, segregating affected product on hand to prevent distribution, destroying affected product on hand, diverting affected product to other non-food applications, or reworking affected product if appropriate.
    Examples of preventing the problem from occurring again include, but are not limited to: permanently disqualifying the failing supplier, putting the failing supplier on an increased verification schedule, retraining employees who handle incoming product, and reassessing your receiving and verification procedures.

• Verification Activities
o Relying on supplier guarantees may not be an appropriate verification activity. Because you did not specify the hazards being controlled in this step, the control and verification activities cannot be evaluated.

Preventive Control 3

• Parameter
o The parameter being measured is not specifically stated.

• Monitoring
o How
 Does not state how the Bills of Lading will be verified (visually, electronically in a database, etc.)

• Corrective Action
o Does not specifically state what will happen if an inappropriate label is applied, how the problem will be correct, and how the problem will be prevented from happening again. Review 21 C.F.R 507.42.

• Verification Activities
o Does not document the frequency with which verification activities will be performed and who will be responsible for them. Because this is a preventive control, must review and sign these records within 7 days of creation.

• Records
o Are there other records that are used to record any of the steps in this process? If so, they need to be described here.

Preventive Control 4

In your written response dated August 19, 2019, you indicated that you are using the National Renderers Association White Paper titled, “Thermal Validation Data for Rendering”, published June 2016. The parameters you reference appear to most closely follow the charts contained in the Industry White Paper “Thermal Parameters for Raw Beef Materials Utilized in Rendering” (Pond, et. al, 2016). Please note that this paper specifically refers to 7.0 of 9.0 log10 reduction of Salmonella, and uses internal product temperature as a parameter. Your hazard analysis and preventive controls plan appears to use air temperature as a parameter.

• Parameter
o The parameter being measured is not specifically stated, for example, “cooker air temperature of 165F”, or “internal product temperature of 165F”, etc. Additionally, the parameter doesn’t document if the temperature of the cooker should be above or below 165F.
o Because the cooker is continuous, the speed of the cooker may be critical parameter.

• Monitoring
   o What
    Does not specify if the temperature being measured is air temperature or internal product temperature.
    Because the cooker is continuous, monitoring of the cooker speed, or monitoring that the speed control mechanism is locked or disabled against changes may be appropriate.

o Frequency
 Continuous recording may not be appropriate without a documented periodic visual check by the operator.

• Corrective Action
o Documents only that the cooker will turn off, but does not document what will be done with the product in the cooker. Examples of appropriate corrective actions can include segregation for evaluation, destruction of all product in the cooker, root cause investigation, retraining employees, and repairing equipment. Additionally, corrective actions also must address what will be done to keep the problem from happening again.

• Verification Activities
o Because this is a preventive control, a PCQI must review and sign these records within 7 days.
o Verification of process monitoring instruments, such as calibration of the thermocouples, temperature indicators, temperature recorders, chart timing and speed, and motors that control conveyor speed may be appropriate.

• Records
o All records related to this preventive control should be named in the “records” section, including calibration and recording documents.

Preventive Controls 5-9

• Parameter
o The parameters being measured are not specifically stated, for example, “presence of absence of chemical odors”, “presence of absence of unnatural materials”, “presence of absence of metal”, or “trailer condition”.

Conclusion

This is not intended to be an all-inclusive list of observations regarding your food safety plan, preventive controls plan, or hazard analysis. It is your responsibility to maintain compliance with the Federal Food, Drug, and Cosmetic Act, and the Agency will continue to monitor your progress.

If you have questions, or would like to provide a response to the comments listed in this letter, please contact Compliance Officer Jessica D. Weber.

Sincerely,
/S/
Jessica D. Weber Compliance Officer
Baltimore District Office Human & Animal Food Division East II
Office of Regulatory Affairs
U.S. Food and Drug Administration
T:410-779-5407
M:443-280-1276
jessica.weber@fda.hhs.gov

Cc:
Pennsylvania Department of Agriculture
Bureau of Plant Industry
Dr. Ruth A. Welliver, Director
2301 N. Cameron Street
Harrisburg, Pennsylvania 17110