- Burnette Foods, Inc.
- Issuing Office:
- Detroit District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
March 24, 2014
Mr. William R. Sherman
Burnette Foods, Inc.
200 State Street
East Jordan, MI 49727
Dear Mr. Sherman:
The Food and Drug Administration (FDA) conducted an inspection of your food facility where you manufacture acidified food, including hummus, located at 87171 County Road 687, Hartford, Michigan on November 26 through December 4, 2013. The inspection revealed serious violations of the regulations for acidified foods, Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control, and Part 114, Acidified Foods, (21 CFR 108 and 114). Accordingly, we have determined that your acidified food products are 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 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. You can find the Act and the Acidified Food regulations through links on FDA’s home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (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, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
Our office is in receipt of your response dated December 12, 2013 to the FDA 483, Inspectional Observations issued at the close of the inspection on December 4, 2013. The response was received in our office on December 20, 2013. We have reviewed the response and find the corrective actions to be inadequate, in that, you have not provided the revised processing records and batch sheets. We are aware you submitted a revision to the filing for shelf stable hummus on January 21, 2014 through the LACF Website. However the filing was returned to you with the request for additional information.
Your significant violations were as follows:
1) A commercial processor engaged in processing acidified foods in any registered establishment shall process each food in conformity with at least the scheduled processes filed under 21 CFR 108.25(c)(2) in order to comply with 21 CFR 108.25(c)(3)(i). However your firm failed to process your acidified foods in conformity with at least the scheduled processes filed under 21 CFR 108.25(c)(2). Specifically,
a. Your firm’s filed scheduled process for Shelf Stable Hummus, FCE 03664; SID: 2013-07-29/001 has a process temperature of (b)(4). However, your manufacturing records show that the hummus manufactured on November 18, 2013 had one batch processed at (b)(4) and (b)(4) batches processed at (b)(4).
b. Your firm’s filed scheduled process lists critical factors of: minimum initial temperature of (b)(4); a hot fill and hold of for (b)(4) minutes; and container headspace and closure are sterilized by the hot product with an inversion of (b)(4) minutes prior to cooling. On November 26, 2013 during the processing of hummus lot #330131, the investigator observed you using raw materials at warehouse temperature of ((b)(4)), not holding packaged product for (b)(4) minutes prior to cooling, and not inverting the product prior to cooling.
Your December 12, 2013 response indicated you were working with a process authority to revise your filing with FDA. As discussed above, FDA received your filing on January 21, 2014, and it has been returned with the request for additional information.
2) Your firm failed to fully reprocess, thermally reprocess as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance a portion of food which deviated from a scheduled process, as required by 21 CFR 114.89. Specifically, hummus manufactured on November 18, 2013 was not manufactured according to the scheduled process for this product (FCE 03664; SID: 2013-07-29/001). The scheduled process temperature for this product is (b)(4). One batch was processed at (b)(4) and (b)(4) batches were processed at (b)(4). There were no process deviation records for these batches. Finished product was shipped on November 21, 2013.
Your response indicated all critical factors were being met but that your records did not indicate this. You also indicate that you have revised your records. However, you did not provide any revised records in your response.
This letter is not intended to be an all-inclusive list of deficiencies in your manufacturing facility. It is your responsibility to ensure that all of your products comply with the Act, the acidified food regulations (21 CFR 108 and 114), the Current Good Manufacturing Practice regulation for food (21 CFR 110), and other applicable regulations. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction as well as application of the emergency permit provisions of 21 CFR 108.
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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Catherine Quinlan, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issues in this letter, please contact Ms. Quinlan at 313-393-8153.
Glenn T. Bass
Detroit District Office
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