Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
August 12, 2013
In reply refer to Warning Letter SEA 13-26
Juanita S. Carmack, Owner
Carmack Industries, LLC
8016 West Main Street
Rathdrum, Idaho 83858
Dear Ms. Carmack:
The United States Food and Drug Administration (FDA) conducted an inspection of your acidified food manufacturing facility, located at 8016 West Main Street, Rathdrum, Idaho, from March 28, 2013, through April 23, 2013. 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 the inspection of your facility, product labels for your Taco Chic Salsa Medium 32 oz. salsa product were collected. We have reviewed your product labels and find that your labels cause your product to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).
We have received your letter dated April 25, 2013, written in response to the Form FDA 483, Inspectional Observations, issued to you on April 23, 2013. Your response is inadequate in that it lacks sufficient detail and is not fully responsive to the noted violations. We have included our comments regarding your response following each of the below violations.
Acidified Food Violations
During our inspection, we observed the following significant violations:
- 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: Taco Chic Salsa in Mild, Medium, and Hot, 16 oz. and 32 oz. glass jars. These products were determined to be acidified foods by your process authority in April of 2012 as evidenced by process source documentation obtained by our investigators during the inspection.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic) either electronically or by paper submission. Publications addressing both methods of filing can be found at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm.
In addition, your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form 2541 with the FDA, as required by 21 CFR 108.25(c)(1).
For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/Guidance Regulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm222618.htm.
Your response letter included a copy of Form FDA 2541a, with a statement that the filing had been submitted; however, as of the date of this letter, the Center for Food Safety and Applied Nutrition has not received your scheduled processes. In addition, your response letter did not address how you will ensure this violation does not recur in the event you begin processing a new product.
- Your firm failed to 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, 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). Specifically,
a) Your firm failed to maintain records demonstrating that your salsa products are held at (b)(4)ºF for at least (b)(4) minutes. Your process authority identified, as a critical factor, that your salsa product be brought to at least (b)(4)ºF for at least (b)(4) minutes.
b) Your firm failed to routinely document finished equilibrium pH for your salsa products. Your process authority identified, as a critical factor, that your salsa products have a finished equilibrium pH of (b)(4) or lower. Our investigator identified at least 21 batch records for salsa product manufactured by your firm in the year prior to be missing results for pH measurement. You acknowledged during the inspection that this is a step that is sometimes forgotten.
c) Your firm failed to maintain records demonstrating that the finished containers for your acidified product are immediately inverted for at least (b)(4). Your process authority identified the inverting of closed containers for at least (b)(4) as a critical factor.
Your response letter included a revised Record of Process Canning; however, it is not clear from the blank record you included how you will ensure recorded times will document the actual duration of the critical step. For instance, the (b)(4) minutes your products are held at (b)(4)ºF and the inverting of your finished containers of product for at least (b)(4). Further, your response did not address the failure of your firm to routinely document finished equilibrium pH for your salsa products, or more specifically, how you will prevent recurrence of this violation, for instance, whether retraining will occur. You have indicated that canning forms will not be filed until they have been reviewed for completion, yet your forms have no identified location to document this review.
- Your firm failed to employ appropriate quality control procedures to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a). Specifically,
a. Your firm failed to maintain records documenting calibration for thermometers used for measuring in-process and hot fill product temperatures. During the inspection it was determined that your firm was using a Record of Process Canning that lacked a location to document the calibration of thermometers.
b. Sufficient control is not exercised in accordance with 21 CFR 114.80(a)(2) so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Specifically,
i. Records are not consistently maintained to demonstrate that your pH meter is periodically standardized. Your batch records were revised on/about April 2012, and in the process, the location to document pH meter calibration was removed. In addition, one batch record identified during the inspection that did contain information on pH meter calibration documented only that a person performed the calibration, and not the recording of the actual results.
ii. Your firm's pH buffers are expired. The pH 4.01 buffer had an expiration date of October 2006, and the pH 7.0 buffer had an expiration date of September 2006. During our inspection your pH meter would not calibrate when placed in the expired pH 4.01 standard buffer.
Procedures for standardization of pH meters and product pH measurement can be found in 21 CFR 114.90.
Your response letter included a revised Record of Process Canning that has a location to document thermometer and pH meter calibration; however, your response did not address how you will prevent recurrence of this violation, for instance, how you will ensure that obsolete forms are not used. Your response included documentation that a new pH meter and buffers have been purchased; however, your response did not address how you will prevent recurrence of this violation, for instance, how you will ensure that buffers are monitored for expiration. In addition, your revised Record of Process Canning indicates that only the individual performing these critical steps is documented and not the actual values obtained. Further, as noted above, to prevent recurrence, you have indicated that canning forms will not be filed until they have been reviewed for completion, yet your forms have no identified location to document this review.
- Your firm failed to maintain production records of examination of raw materials, packaging materials, finished products, and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels as required by 21 CFR 114.100(a). Specifically, records are not maintained documenting examination of raw materials or finished product evaluations.
Your response letter included a revised Record of Process Canning that has a location to document examination of raw materials and finished product evaluations; however, as noted above, the record indicates that only the individual performing these critical steps is documented and not the actual results of the evaluations.
- Your firm failed to prepare and maintain current procedures for recalling products that may be injurious to health; identifying, collecting, warehousing, and controlling products; determining the effectiveness of recalls; notifying FDA of any recalls, and implementing recall programs as required by 21 CFR 108.25(e). Specifically, your firm does not have a written recall procedure.
Your response letter included a Recall Action Plan. Your plan does not address how you will warehouse returned recalled products and how you will control recalled product that may still be in your possession to prevent redistribution of the product. We recommend you review the Guidance for Industry: Product Recalls, Including Removals and Corrections at http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm which is intended to assist you in handling all aspects of a product recall, and includes a checklist of documentation and information that should be maintained by your firm.
Misbranded Food Violations
During the inspection our investigators collected a copy of your Taco Chic Salsa Medium 32 oz. salsa product label. Our review identified the following significant violations:
1. Your Taco Chic Salsa Medium product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears nutrient content claims, but does not meet the requirements to make the claims. Under section 403(r)(l)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l )(A) of the Act. Specifically,
a. Your product label and your website at www.tacochicsalsa.com bear the nutrient content claim “low carbohydrates”. FDA has not defined the nutrient content claim “low carbohydrates”; therefore, this claim cannot be used.
b. Your product label and product website at www.tacochicsalsa.com bear the nutrient content claim “no fat”, but the labeling does not bear a statement indicating that this type of food typically has no fat. Per 21 CFR 101.13(e)(2), any claim for the absence of a nutrient in a food, or that a food is low in a nutrient when the food has not been specially processed, altered, formulated, or reformulated to qualify for that claim, shall indicate that the food inherently meets the criteria and must clearly refer to all foods of that type and not merely to the particular brand to which the labeling attaches (e.g., “corn oil, a sodium-free food”).
c. Your product label bears the nutrient content claim “no sugar”. However, it fails to bear the statement “low calorie”, “reduced calorie”, or to bear a relative claim of special dietary usefulness labeled in compliance with 21 CFR 101.60(b)(2), (b)(3), (b)(4), or (b)(5); or to bear the statement “not a reduced calorie food”, “not a low calorie food”, or “not for weight control”, as required by 21 CFR 101.60(c)(1)(iii). A food cannot bear the claim “no sugar” unless it contains less than 0.5 g sugars per reference amount customarily consumed and per labeled serving, in accordance with 21 CFR 101.60(c)(1)(i).
2. Your Taco Chic Salsa Medium product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the labels state the product is “FDA Approved.” This statement is false and misleading because FDA does not approve food products.
3. Your Taco Chic Salsa Medium product is misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but does not declare the ingredients listed by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4(a)(1). Specifically,
a. Your product label does not list the ingredients in descending order of predominance by weight.
b. Your product label ingredient list declares “red tomatoes”. Canned tomatoes, tomato puree, and tomato paste are used in the production of your products. These tomato products are standardized foods. Per 21 CFR 155.190, canned tomatoes may be declared as “tomatoes”, but not as “red tomatoes”. Per 21 CFR 155.191, tomato concentrates such as tomato paste and tomato puree must be declared as “tomato paste” and “tomato puree”, respectively, but not as “red tomatoes”.
4. Your Taco Chic Salsa Medium product is misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as specified in 21 CFR 101.9. Specifically,
a. The “Nutrition Facts” panel does not include a declaration of the amount of trans fat present in the product in accordance with 21 CFR 101.9(c)(2)(ii).
b. The equivalent metric quantity for the serving size is not rounded in accordance with 21 CFR 101.9(b)(7)(ii).
c. The number of servings per container is declared as 32. A single serving is declared as weighing 34.96094 g, which indicates a 32 oz. jar would contain approximately 1119 g. However, the label states that each jar contains 946 g, approximately 27 servings per container.
The above violations are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Additional Labeling Comments
- The ingredient listing contains intervening information, which should not be included, per 21 CFR 101.2(e). Your ingredient statements, in part, include the following intervening material (see underlined words):
o “fresh green jalapenos”;
o “fresh garlic”;
o “fresh cilantro”;
o “natural spices”; and
o “Refrigerate After Opening” (we note this should be placed in a location separate from the ingredient list).
- Your Taco Chic Salsa Medium product nutrition facts information is not in an appropriate format as specified in 21 CFR 101.9. Specifically:
o The nutrient information for vitamins and minerals does meet the formatting requirements in 21 CFR 101.9(d)(8). Vitamins and minerals must be separated from information on other nutrients by a bar and shall be arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, Iron 4%) or may be listed in two columns in accordance with 21 CFR 101.9(d)(12).
o The label declares “Calories” and “Calories from Fat” on two separate lines. Information on calories must be declared in one line, in accordance with 21 CFR 101.9(d)(5).
o The vitamin and mineral information and the footnote must be located inside of the box with the rest of the nutrition information, in accordance with 21 CFR 101.9(d).
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)). 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.
Within 15 working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be sent to the following address: Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 302-0427.
Celeste M. Corcoran, PhD
Acting District Director
Idaho Department of Health and Welfare
450 West State Street, 4th Floor
Boise, Idaho 83720-0036