Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204
September 15, 2015
Danielle (NMI) Coursey, President, Co-Owner
Michael R. Coursey, Vice-President, Co-Owner
Backwoods Manufacturing, Inc
591 Main Parkway
Tahlequah, OK 74464
Dear. Ms. Coursey,
On March 24-26, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 591 Main Parkway, Tahlequah, OK, where you manufacture a variety of acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 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 link in 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 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 Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.
During our inspection, we observed the following significant violations:
1. You failed to exercise sufficient control including frequent testing and recording of results so that the finished equilibrium pH values were not higher than 4.6, in accordance with 21 CFR 114.80(a)(2). Specifically, review of your production records for (b)(4) Black Bean and Corn Salsa reveals you did not measure and document the critical control measurement of finished equilibrium pH value for each batch you manufactured, including:
a. The March 17, 2015, production record for lot (b)(4), which consisted of (b)(4) individual batches, lacks any pH values.
b. The October 23, 2014, production record for lot (b)(4), which consisted of (b)(4) individual batches, contains only one pH value.
c. The June 9, 2014, production record for lot (b)(4), which consisted of (b)(4) individual batches, contains only one pH value.
d. The April 17, 2014, production record for lot (b)(4), which consisted of (b)(4) individual batches, contains only one pH value.
In addition, you did not measure and record a finished equilibrium pH value for any of the (b)(4) lots of (b)(4) Avocado Salsa Verde you manufactured in 2014 and 2015. You measured and documented an in-process pH value after your product was cooked, prior to filling, and this is the only pH value you measured.
Your firm’s April 7, 2015 response letter indicates you will begin measuring and recording a finished equilibrium pH value for each individual batch of all acidified food products; however, you did not provide evidence to support that this new procedure has been implemented.
2. You must maintain production and processing records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, and containing sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production, to comply with 21 CFR 114.100(b).
However, review of your production records for Avocado Salsa Verde reveals that you failed to maintain production and processing records showing adherence to the scheduled process, including records of pH measurements and other critical factors. Specifically, you did not document the critical controls measurements of pH and heat treatment times and temperatures, nor are you monitoring the fill temperature.
Your response letter included a copy of a Hot Fill Production Report, which you intend to use to document the hold times and temperatures, the fill temperature, and the pH. However, your response does not indicate whether this pH value is the in-process pH value you are currently measuring, or the final equilibrium pH value.
3. As a commercial processor engaged in the processing of acidified foods you must prepare and maintain files on a current procedure for use for products under the processor’s control, including plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; and for determining the effectiveness of recalls; for notifying the FDA of any recalls; and for implementing recall programs, to comply with 21 CFR 108.25(e). However, you failed to prepare a written recall procedure.
We acknowledge that your response letter states you are creating a written recall procedure and in the future you will conduct mock recalls. We will verify this corrective action during the next inspection.
4. Instruments used for measuring conditions that control or prevent the growth of microorganisms must be adequately maintained, to comply with 21 CFR 110.40(f). You are not documenting the calibration of your pH meter or the accuracy checks of your thermometers. Further, (b)(4) of the buffer solutions used to calibrate your pH meter expired in 2013.
Your response letter indicates a thermometer calibration log was created to document the accuracy checks for the thermometers. However, you did not include whether or not the calibration of your pH meter will be documented. In addition, your response did not include corrective action in response to your use of expired buffer solutions.
Furthermore, as a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Since you moved your processing facility to a new location on November 15, 2014, you are required to file your scheduled processes under a new Food Canning Establishment (FCE) number. You previously had (b)(4) filed with the FDA under your original FCE number, but you have not filed all of these processes under your active FCE number. If you intend to process these additional products at your new location, you must file these scheduled processes with FDA.
Additionally, we acknowledge you consider all (b)(4) as one batch, and are identifying all batches with one lot code. Your response states rather than adding (b)(4) to your lot code, in the event product needs to be recalled you would recall the entire lot, even if only one batch of product fails to adhere to the scheduled process. We will verify your new procedure of monitoring and recording critical limit factors for each batch during the next inspection.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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 er-inspection-related costs.
You should notify this office in writing within fifteen (15) business days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled processes have been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Jamie M. Bumpas, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Bumpas at 214-253-5336.
Reynaldo R. Rodriguez, Jr.
Dallas District Director