Inspections, Compliance, Enforcement, and Criminal Investigations
Best of Texas, Inc. 8/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850-3229
August 16, 2011
RETURN RECEIPT REQUESTED
Michael G. Loyd, Owner and Vice President
Best of Texas, Inc.
255 W. Garner Rd.
Detroit, Texas 75436
Dear Mr. Loyd:
On February 15 to 22, 2011, and May 19 to 24, 2011, the U.S. Food and Drug Administration (FDA) conducted inspections of your facility located at 255 W. Garner Rd., Detroit, Texas, where you manufacture several varieties 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 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 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 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 Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
During our inspection, we observed the following significant violations:
1. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the 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).
Specifically, your firm has failed to file a scheduled process for the following acidified foods that your firm manufacturers: Hot Pepper Relish, Baby Beet Pickles, Hot Onion Relish, Hot Picante Sauce, Mild Picante Sauce, Chow Chow Relish, Blackeyed Pea Relish, Corn Relish, and Bread & Butter Jalapenos.
Scheduled process information for acidified foods much be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/ProductSpecificInformation/AcidifiedLowAcidCannedFoods/default.htm.
For additional information on the types of products FDA considers to be acidified, please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatorvInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.
2. You must maintain processing and production 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, you failed to maintain processing and production records showing adherence to the scheduled process, including records of pH measurements and other critical factors. Specifically, your firm did not document the critical control measurements of finished equilibrium pH, hot water bath temperature or bath time for at least (b)(4) lots of various acidified foods manufactured by your firm. From 3/9/11 through 4/19/11 you did not document the finished equilibrium pH of at least (b)(4) lots of acidified foods manufactured by your firm.
3. You must maintain records identifying the initial distribution of your acidified products to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use, in accordance with 21 CFR 114.100(d). However, our inspection found that you do not always maintain records identifying initial distribution of specific lots of your acidified products.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that 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 action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
You should notify this office in writing within fifteen (15) working 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 process has 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 Seri L. Essary, 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. Essary at (214)253-5335 or by email at Seri.Essary@fda.hhs.gov.
Reynaldo R. Rodriguez, Jr.
Dallas District Director