Inspections, Compliance, Enforcement, and Criminal Investigations

Faye's Texas Naturals 4/25/16

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204 

 

April 25, 2016
 
2016-DAL-WL-18
 
WARNING LETTER
 
UPS OVERNIGHT
         
Courtney G. Cantrell, Owner
Faye’s Texas Naturals                                                                  
123 South Courthouse Square
Goliad, Texas 77963
 
Dear Ms. Cantrell:
 
Between the dates of January 27, 2016 to February 10, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 123 South Courthouse Square, Goliad, Texas 77963; where you manufacture acidified products. 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), Part 114, Acidified Foods (21 CFR Part 114) and Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110). 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 it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through the 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 related 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 Part 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, (b)(3)(A) 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).
 
As a commercial processor engaged in the thermal processing of acidified foods you must, (b)(3)(A) 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 did not provide FDA with the scheduled processes for Corn Petin Relish in a 10-oz jar, Chili Petin Picante Caliente in a 16-oz jar, and Chili Petin Picante Muy Caliente in a 16-oz jar. These acidified products have been manufactured by your firm since January, 2013.
 
Your firm has a scheduled process letter for Corn Petin Relish dated February 18, 2005 that classifies this product as an acidified food product. Your firm has scheduled process letters for Chili Petin Picante Caliente and Chili Petin Picante Muy Caliente dated January 29, 2016 which classify these products as acidified food products. Scheduled process information for AF products must be submitted on Form FDA 2541e (Process Filing for Acidified Method). More information on filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: www.fda.gov/Food/Guidance Regulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007437.htm
 
2.    Your firm failed to have a scheduled process established by a qualified person who has expert knowledge, as required by 21 CFR 114.83. Specifically, your firm does not have a scheduled process for Chili Petin Pepper Sauce packaged in a 2-oz bottle. Your firm is using a (b)(4) method to manufacture this product that has not been evaluated by a Process Authority.
 
We acknowledge your response letter to the FDA 483, dated February 22, 2016. The response is inadequate because you did not address having this product evaluated. 
 
3.    Your firm failed to exercise sufficient control including frequent testing and recording of results so that finished equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). In addition, your firm is not conducting finished product equilibrium testing for any of your acidified food products. Specifically, your firm is not conducting finished equilibrium pH testing for the products of Corn Petin Relish in a 10-oz jar, Chili Petin Picante Caliente in a 16-oz jar, Chili Petin Picante Muy Caliente in a 16-oz jar, and Petin Pepper Sauce in a 2-oz bottle. Furthermore, during the inspection you did not have a pH meter to conduct finished equilibrium pH testing.
 
We acknowledge your voluntarily recall on February 10, 2016 consisting of all lots of the above mentioned acidified products and your voluntary destruction of remaining stock. Your firm is required to prepare and maintain a procedure for recalling products that may be injurious to health, as required by 21 CFR 108.25(e). Within your response you state that you have attended classes to properly monitor pH levels and you have purchased a new pH meter. The response is inadequate because you have not provided us with the details of when the pH will be tested and how and where this information will be recorded and maintained.
 
4.    Your firm failed to maintain processing and production records showing adherence to the scheduled process, including records of critical factors, as required by 21 CFR 114.100(b). Specifically, your firm does not maintain processing and production records, which document the critical factors of finished product equilibrium pH, processing time, and fill temperature which are listed within the scheduled process letters for your acidified food products. Your firm only monitors and documents the processing temperature.
 
Within your response letter you state that your firm will start documenting pH recordings. The response is inadequate because you have not provided us with the details of when the pH will be tested and how and where this information will be recorded and maintained; additionally, your response does not address the documentation of the other critical factors listed in the scheduled process letters.
 
5.    Your firm failed to adequately maintain instruments used for measuring, regulating, and recording conditions that control or prevent the growth of microorganisms, as required by 21 CFR 110.40(f). Specifically, your firm is not calibrating or conducting accuracy checks for your thermometers. You could not provide any records of calibration and/or accuracy checks for your thermometers.
 
We acknowledge your response included documentation that you have purchased a thermometer. In addition, you provided a website printout of the thermometer you have purchased. The response is inadequate because you have not provided evidence of the thermometer’s calibration or intended calibration schedule. In addition, the thermometer which you have chosen is a pocket style with a five inch stem which is not long enough to adequately monitor the temperature of product contained within your production kettle.
 
6.    Your firm failed to apply adequate manufacturing coding, as required by 21 CFR 114.80(b). Specifically, your firm does not apply a manufacturing code to the acidified product Petin Pepper Sauce packaged in a 2-oz bottle. Your firm has been manufacturing this product since 2013 without a manufacturing code. Each container or product should contain an identifying code permanently visible to the naked eye.
 
Your response letter is inadequate because it does not address the manufacturing coding deficiency associated with the acidified product, Petin Pepper Sauce.
 
As a responsible official of a facility that manufactures/processes, packs, and/or holds food for human consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
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 and the products that you manufacture are in compliance with all requirements of the Act and federal regulations. It is your responsibility to review all products that you manufacture and distribute commercially to determine if they are subject to the acidified foods regulations (21 CFR 114). 
 
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 inspection conducted subsequent to an inspection that identifies noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance had been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluation of the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)].
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the steps that you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for your delay and state when any remaining deviations will be corrected. 
 
Your reply should be sent to the Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204, Attention Paul E. Frazier, Compliance Officer. If you have questions regarding any issue in this letter, please contact Mr. Frazier at (214) 253-5340.
  
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
  
Cc:    
Lori Woznicki, Food and Drug Inspections Branch Manager
Division of regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756

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