Inspections, Compliance, Enforcement, and Criminal Investigations
J.M. Smucker, LLC 3/22/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
March 22, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 28
Chief Executive Officer
J.M. Smucker, LLC
One Strawberry Lane
Orrville, Ohio 44667
Dear Mr. Smucker:
An inspection of your facility located at 1050 Stanton Street, Ripon, Wisconsin,was conducted by investigators from the Food and Drug Administration (FDA) on January 5, 6, 9, and 11, 2012. This inspection verified that your firm manufactures and distributes food products, specifically acidified food products.
As a manufacturer of acidified foods, 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 products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 114, Acidified Foods (21 CFR 114). 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 acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. In addition, based upon certain criteria in Part 114, acidified foods may be adulterated within the meaning of section 402(a)(3) of the Act, 21 U.S.C. § 342(a)(3), in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or 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 may have become contaminated with filth, or whereby they may have been rendered injurious to health. Your firm’s failure to fulfill the requirements of 21 CFR 108.25 and the mandatory requirements of 21 CFR 114 renders your Pumpkin Butter, in all brand names and packaging sizes, adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
We acknowledge your firm’s February 2, 2012, response to the issued FDA Form 483, Inspectional Observations, written by David R. Thomas, Vice President, Quality Assurance, and provide comment within each item cited in this letter. Your letter has been made a part of the Minneapolis District’s permanent file for your firm.
The most significant violations noted during the inspection are:
- Failure to process the acidified product in conformity with at least the scheduled process filed with FDA for Pumpkin Butter (SID (b)(4)) which requires a (b)(4). While you are processing this product to achieve a (b)(4), you are not (b)(4) to ensure that (b)(4) is achieved after the product is filled, 21 CFR 108.25(c)(3)(i).
In your written response you state that you view your firm’s practice of a (b)(4) and subsequent (b)(4) as consistent with that filed with FDA. However, your response does not provide any evidence supporting why this process would be considered at least equivalent to the filed process, e.g., (b)(4).
You are reminded that 21 CFR 108.25(c)(2) requires that you provide FDA information on the scheduled process including as necessary conditions for heat processing and source and date of the establishment of the process for each acidified food in each container size. Should you continue with the above process, you need to file the information required by 21 CFR 108.25 for this process.
- Failure to have records of the actions taken to rectify departures from the scheduled process which may have a bearing on public health or safety of the food product, and the disposition of the portion of the product involved in accordance with 21 CFR 114.100(c). Specifically, two production lots of pumpkin butter failed to consistently meet the (b)(4). during the filling operation and no notation of the events, the results of an evaluation or product disposition was made.
In your response you state that you did not release these lots of product into distribution and that your standard operating procedure is to destroy the product subject to such deviations. Further, you commit to maintaining records showing compliance with this procedure in the future. This is an adequate correction for future deviations and will be evaluated at the next inspection.
- Failure to provide the FDA with requested information deemed necessary to determine the adequacy of the process to comply with 21 CFR 108.25(c)(3)(ii). Specifically, you did not provide any process source documentation, e.g., a letter from a processing authority establishing the processing parameters, heat penetration date or the equivalent, for the (b)(4) process that your firm was using for the pumpkin butter that you were processing.
In your response, you appear to have interpreted this item as a requirement that you have an outside process authority. That is not the intent of this citation. You must maintain information which provides the results of the formal evaluation conducted by your process authority and this information must be made available to the FDA upon request so that we may evaluate that information in relation to the filed scheduled process.
- Failure to have personnel involved in conducting operations required for control of the scheduled process supervised by an individual who has satisfactorily completed an approved school (such as Better Process Control school), in that you have one person who has completed such schooling and that person does not supervise production personnel nor does he work all production shifts when acidified products are manufactured, 21 CFR 108.25(f).
In your response, you note that the individual is available for all production shifts and that the trained individual is not required to be on-site during the production. This is inadequate. The trained individual must be in the immediate supervisory chain of command for the production line employees to go to when unexpected events occur. The individual must be on-site during the production of any acidified product.
Additionally, we note that you have several products which may be acidified which have not been evaluated by a process authority, 21 CFR 108.25(c)(2). In your response you have provided pH and percent of formulation information for several of the products discussed during the inspection and listed on the issued Form FDA 483. Further, you committed to having all of these products evaluated by a process authority prior to submission of a scheduled process. You can also file processing information on products in question for subsequent determination by FDA as to whether these products are acidified foods requiring filing of processing information.
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 costs related to re-inspection. 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 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in enforcement action including seizure, injunction, and emergency permit actions being initiated by the Food and Drug Administration. This letter does not represent a comprehensive review of all of the products distributed by your firm. As CEO, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
Elizabeth A. Waltrip
David C. Brookover
J.M. Smucker, LLC
1050 Stanton Street
Ripon, Wisconsin 54971