Inspections, Compliance, Enforcement, and Criminal Investigations
Border Foods, Incorporated 9/9/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
September 9, 2009
RETURN RECEIPT REQUESTED
Ref: DEN-09-08 WL
Randy E. Clark, Chief Executive Officer
Border Foods, Incorporated
4065 J. Street S.E.
Dear Mr. Clark:
On April 6, 9-10, 13-17, May 14-15,2009, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 4065 J. Street S.E., Deming, New Mexico. The inspection revealed that you manufacture several varieties of acidified food products at this facility.
We found that you have serious deviations from the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114). As a manufacturer of acidified food products, 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. 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 food products 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. In addition, based on certain criteria in Part 114, acidified food products 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. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be accessed through links in FDA's home page at www.fda.gov.
During the inspection, the FDA investigators discussed with you observations noted on the Form FDA-483, Inspectional Observations, which was issued to you on May 5, 2009. The significant violations were as follows:
1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, 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). However, your firm has failed to file a scheduled process for the following acidified foods: jalapeno puree, red jalapeno puree, and no heat jalapeno puree.
Scheduled process information for acidified foods must be submitted on Form FDA 2541 a (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/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/
2. You must manufacture acidified foods according to the scheduled process filed with the FDA as required by 21 CFR 114.80(a)(1). However, your firm failed to manufacture
diced green chilies and red or green jalapenos dehydrobrine, for example, according to the filed scheduled processes:
a. The filed scheduled process for diced green chilies, 4 oz can, (b)(4) lists a maximum pH (b)(4) method of acidification as batch, and an acidifying agent of citric acid. The pH for this product exceeded (b)(4) batches produced on 10/17/2008.
b. The filed scheduled process for red or green diced jalapeno dehydrobrine, (b)(4) lists a direct method of acidification, but you are manufacturing with an indirect method. In addition, this filed scheduled process lists a maximum pH (b)(4) but the production records have a maximum operating pH of (b)(4) dehydrobrine jalapenos and (b)(4) dehydrobrine jalapenos.
In addition, your firm failed to note these departures from scheduled processes having a possible bearing on public health or the safety of the food and did not maintain a separate file or log that identifies departures from the scheduled process, the action taken to correct them, and the disposition of the product involved as required by 21 CFR 114.100(c).
3. Your firm failed to adequately maintain instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms as required by 21 CFR
a. Your firm does not calibrate the thermometers used to monitor the temperature of the heat treatment of your acidified food products. Specifically, there is no documented evidence of calibration of the hand held thermometers and for several (b)(4) thermometers within the last year.
b. Your firm's pH calibration records are outside of the acceptable slope range of (b)(4) and no corrective action was taken. For example, your "pH Meter Verification Log" showed a value of (b)(4) on July 31, 2008, and no corrective action was documented.
4. Your firm failed to mark containers with an identifying code specifying the establishment where the product was packed, product contained therein, year, date, and packing period as required by 21 CRF 114.80(b). Specifically, 5 gallon (40 pound) pails of diced green chilies and diced jalapenos are stored without any coding on the individual containers.
5. Your firm failed to examine containers often enough to ensure that containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4).Specifically, inspection of your firm's finished product warehouse revealed at least (b)(4) swollen 40 pound tubs of diced green chilies with best by date 20101016 and at least (b)(4) swollen 40 pound tubs of diced green chilies with best by date of 20101014 were being stored in the finished goods warehouse. Also, these pallets contained swollen bags and broken pails of finished product along with bags of green chilies that had broken open leaving dried product on the floor. We acknowledge that this swollen product was later separated and voluntarily destroyed on May 14, 2009, however, the cause of the swelling needs to be addressed as well as your firm's evaluation of finished product.
We received your June 11, 2009, response to the FDA 483, Inspectional Observations that the FDA investigators issued at the conclusion of the most recent inspection of your firm. We have completed our review of your response and have determined that your response is inadequate to address all the violations that FDA documented at your firm. Although you state that several of the violations have been corrected; some of these corrections can only be verified at a follow-up inspection of your firm. In addition, you did not submit any documentation for corrections that you have completed and implemented such as the (b)(4)
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure; injunction and/or issuance of an Order of Need to obtain and hold a temporary Emergency Permit.
You should notify this office in writing of the steps you have taken to bring you firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken of will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and then the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating the corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Carolyn A. Pinney at (303) 236-3024.
H. Thomas Warwick, Jr.
Denver District Director