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  5. Saputo Dairy Foods USA, LLC - 481087 - 03/17/2016
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Saputo Dairy Foods USA, LLC MARCS-CMS 481087 —

Saputo Dairy Foods USA, LLC

United States

Issuing Office:
Baltimore District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 


CMS# 481087
March 17, 2016
Mr. Lino A. Saputo Jr., CEO and President
Saputo, Inc.
6869, Metropolitain, East
Montréal Qc H1P 1X8
Dear Mr. Saputo:
We inspected your firm, located in Frederick, MD, between August 31, 2015 and September 22, 2015. The inspection found that your firm manufactures low-acid canned foods, such as portion controlled non-dairy creamer cups in a variety of flavors. The inspection documented that you have significant deviations from the Low-Acid Canned Foods (LACF) regulations contained in, Title 21, Code of Federal Regulations, Part 113 (21 CFR 113), Emergency Permit Control regulations contained in 21 CFR 108, and the regulations for current Good Manufacturing Practices (GMP) in Manufacturing, Packing, or Holding Human Food contained in 21 CFR 110.       
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food and low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113. 
Based upon certain criteria in 21 CFR 113, low-acid canned foods may be adulterated within the meaning of section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the acidified and low-acid food regulations through links on FDA’s Internet home page at www.fda.gov.
Your firm’s significant deviations from the Low-Acid Canned Foods regulations (21 CFR 113), Emergency Permit Control regulations (21 CFR 108), and GMPs for Human Food regulations (21 CFR 110) include:  
1)    Failing to process each low-acid canned food in conformity with the schedule process, as required by 21 CFR 108.35(c)(3)(i).
(b)(4) was filed specifying as a critical factor (b)(4) during sterilization, despite the “Microbial Challenge Testing” process recommendation for the (b)(4) machine recommending (b)(4).
2)    A critical factor specified in the scheduled process was not measured and recorded on the processing record to ensure that the factor was within the limits specified in the scheduled process, as required by 21 CFR 113.40(g)(4).
Scheduled processes for the (b)(4) machines at your firm specify the volume of (b)(4) that is needed to sterilize each machine as a critical control factor to achieve commercial sterility. The volume of (b)(4) actually used is not recorded on a processing record by any of your (b)(4) machines or by an operator monitoring the process.
3)    Instruments used for measuring, regulating, and reading conditions that control or prevent the growth of microorganisms are not accurate and adequately maintained, as required by 21 CFR 110.40(f).
Sensors used to monitor (b)(4), a critical factor for the (b)(4), were found on June 6, 2015 to be providing inaccurate readings at the (b)(4) standard. The sensors were not corrected and no investigation was made into the safety of products manufactured on this (b)(4) machine.
4)    A reference device did not have a tag, seal, or other means of identity, as required by 21 CFR 113.40(g)(1)(i)(A).
The temperature indicating device on your (b)(4), did not have a tag, label, numbered seal, or other means of identifying the sensor. It should be noted that a similar deficiency was cited during our previous inspection of your firm ending February 20, 2014.
5)    Processing records are not reviewed within one working day after the actual process to determine completeness of the record and to ensure that the product received the scheduled process, as required by 21 CFR 113.100(b).
Specifically, your firm’s processing batch records from February 1, 2015, May 19, 2015, and August 1, 2015 were all found to have taken three days to undergo review.
We have reviewed your response dated October 12, 2015 and the corrective actions specified may be adequate to address these deficiencies. A follow-up inspection will be needed in order to verify that the corrective actions are effective.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
Furthermore, Section 743 of the Act, 21 U.S.C. § 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.  Re-inspection 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 U.S.C. § 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.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to prevent these violations from recurring. If you can not complete this within 15 working days, state the reason for the delay and the time within which these actions will be completed. Please provide documentation such as submission of updated SUPSID information, photographs, or other relevant information to support the corrections you have implemented or plan to take.
Your response should be directed to: Mr. Ernest F. Bizjak, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions, please do not hesitate to contact Mr. Bizjak by calling (301)796-4081 or sending an email to ernest.bizjak@fda.hhs.gov.
Sincerely yours,
Evelyn Bonnin
District Director
Baltimore District Office
Mr. Michael J. Kerstetter, Plant Manager       
Saputo Dairy Foods USA, LLC                                 
428 E. Patrick Street                                                 
Frederick, MD 21701
Mr. Paul Corney, President and COO
Saputo Dairy Foods USA, LLC
2711 North Haskell Avenue, Suite 3700
Dallas, TX 75204 

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