M circle M Canning Co. 1/29/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
January 29, 2013
Robert W. Mishler, Owner
M circle M Canning Company
350 Crystal Lane
Seguin, Texas 78155
Dear Mr. Mishler:
On September 13 – 24, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 350 Crystal Lane, Seguin, 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 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 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 manufactures: candied jalapenos, roasted garlic salsa, tomato relish, farm fresh salsa, jalapeno relish, pickled okra, corn relish, bread and butter pickles, chow chow, and yellow squash pickles. These products were determined to be acidified foods by your process authority in 2007 as evidenced by process source documentation obtained by our investigators during the inspection.
We acknowledge your attempts to submit process filings to FDA in 2009; however, these filings were returned and need to be re-submitted in order to comply with 21 CFR 108.25(c)(2). We also acknowledge receipt of your letter postmarked October 16, 2012, in which you state that you will submit scheduled processes for your acidified food products. However, as of the date of this letter, scheduled processes for the above products have not been filed.
Scheduled process information for acidified foods must 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:
2. Your firm failed to establish scheduled processes by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, no scheduled processes were established for the following products identified on your firm’s list of Acidified Foods: dill pickles, pickled okra, corn relish, bread and butter pickles, chow chow, candied jalapenos, and pickled yellow squash.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
We acknowledge that in your October 16, 2012, letter you stated that you will have your products evaluated by a process authority; however, as of the date of this letter you have not provided the product evaluations to FDA.
3. You failed to fully reprocess, thermally process 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, in accordance with 21 CFR 114.89. Specifically, review of your production record for Farm Fresh Salsa lot A082712, produced on August 27, 2012, reveals that the record lists a cook or fill temperature of “(b)(4)”. However, your process source letter identifies a fill temperature of (b)(4) for this product.
4. 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, further review of your production records reveals that you failed to maintain processing and production records showing adherence to the scheduled process, including records of pH measurements and other critical factors. Specifically, you did not document the critical control measurements of finished equilibrium pH and/or cook temperature for several lots of acidified foods manufactured by your firm, including:
a. The May 2, 2012, production record for Candied Jalapenos lot A050212 lacks a fill temperature.
b. The May 3, 2012, production records for Roasted Garlic Salsa lots D050312 and E050312, and Corn Relish lots A050312 and B050312, lack fill temperatures.
c. The May 10, 2012, production records for Chow Chow lot A051012 and Chow Chow Habanero lot B051012, lack fill temperatures.
d. The May 11, 2012, production record for Tomato Relish lot A051112 lacks a fill temperature.
e. The June 24, 2012, production record for Bucksnort Candied Jalapenos lot A062412 lacks a fill temperature.
f. The July 31, 2012, production records for Bread and Butter Pickles lot B073112 and Bread and Butter Yellow Squash Pickles lot C073112, lack fill temperatures.
g. The August 10, 2012, production records for pickled okra lot B081012 and “pickles” lot C081012, lack fill temperatures and equilibrium pH measurements.
Additionally, although shipping records provided during the inspection document that you shipped Bob’s Candied Jalapenos lot A053112 to a customer on July 25, 2012, you have no production records for this lot of product.
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.
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.
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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director