Further, FDA reviewed labels of repacked products (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-gordo-spices-llc-639957-09302022
WARNING LETTER
El Gordo Spices, LLC
MARCS-CMS 639957 — SEPTEMBER 30, 2022
Recipient:
Mr. Martin Mendoza
Owner and President
El Gordo Spices, LLC
8201 Eastpoint Dr. Ste 500
Dallas, TX 75227
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
Mr. Martin Mendoza
Owner and President
El Gordo Spices, LLC
8201 Eastpoint Dr. Ste 500
Dallas, TX 75227
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
September 30, 2022
WARNING LETTER
CMS #639957
Dear Mr. Mendoza:
The United States Food and Drug Administration (FDA) inspected your herbs, spice, and seafood repacking and warehousing facility located at 8201 Eastpoint Dr. Ste 500, Dallas, TX 75227 on July 7-15, 2022. During our inspection, FDA investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Based on our inspectional findings, your shelf stable ready-to-eat (RTE) Whole Dried Shrimp and Ground Dried Shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Further, we have reviewed labels of products that you repack (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). These violations cause these products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below. You may find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.External Link Disclaimer
At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the violations found at your firm. To date, we have not received a response to the inspectional observations listed on the Form FDA-483.
Your serious violations were as follows:
Seafood HACCP:
1) You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s Seafood HACCP plan for shelf stable RTE Whole Dried Shrimp and Ground Dried Shrimp products do not list the food safety hazard of allergens. Shrimp is a known allergen. Additionally, your firm does not have an allergen program.
2) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Your firm did not take a corrective action to control sulfiting agents when your process for RTE Whole Dried Shrimp deviated from your critical limit at the receiving product critical control point. Your firm’s Seafood HACCP plan identifies sulfiting agents as significant hazard at a receiving product step. The Critical Limits for each Preventive Measure states, “Incoming lots of RTE Whole Dried Shrimp must be accompanied by a lot by lot certificate stating sulfating agents were not used.” Your firm’s management provided “(b)(4) Specification Sheet” as a lot certificate which states, “May or May Not Contain Sulfites”. According to your Seafood HACCP plan, the corrective action when a deviation from a critical limit occur is to “Test the Lots for sulfiting agents. Reject the lot if (b)(4) ppm or greater.” Your firm was unable to provide testing results for sulfiting agents during the inspection.
Misbranded Foods
3) Your products Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, and Textured Soybeans are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because their labels fail to bear nutrition information (e.g. Nutrition Facts labels), as required by 21 CFR 101.9.
4) Your Ground Dried Shrimp, Whole Dried Shrimp, Ground Cumin, Whole Bay Leaves, Sesame Seeds, and Textured Soybeans products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages as required by 21 CFR 101.15(c)(2). For example, “net weight” or “net wt.” must be declared in both languages, and the Ground Dried Shrimp, Whole Dried Shrimp, and Textured Soybeans labels lack an ingredient statement in the foreign language.
5) Your Ground Dried Shrimp product is misbranded under sections 403(k) and 403(i)(2) of the Act [21 U.S.C. §§ 343(k) and 343(i)(2)] because the product contains artificial coloring and fails to bear labeling stating that fact. Your supplier’s specification sheet for the bulk dried shrimp states that it contains FD&C Red #40 Lake. However, your finished product label for the Ground Dried Shrimp product does not declare color additive FD&C Red No. 40 Lake as required by 21 CFR 101.22(k)(1) and 21 CFR 101.4(s).
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations cited in this letter. Failure to so may result in legal action, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comments:
You must establish and maintain records that document your employees received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as appropriate to the food, the facility and the individual’s assigned duties, as required by 21 CFR 117.4(d).
Your firm may qualify for exemptions from nutrition labeling for certain products. We recommend you review the exemptions in 21 CFR 101.9(j). One exemption, for low-volume products, applies if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. To qualify for this exemption the person must file a notice annually with FDA. Note that low volume products that bear nutrition claims do not qualify for an exemption of this type. See https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption for additional information.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: René R. Ramirez, Compliance Officer, at 1201 Main Street, Ste. 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at (210) 308-1425 or rene.ramirez@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
Program Division Director HAF West 3
Dallas District Director
WARNING LETTER
CMS #639957
Dear Mr. Mendoza:
The United States Food and Drug Administration (FDA) inspected your herbs, spice, and seafood repacking and warehousing facility located at 8201 Eastpoint Dr. Ste 500, Dallas, TX 75227 on July 7-15, 2022. During our inspection, FDA investigators found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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)]. Based on our inspectional findings, your shelf stable ready-to-eat (RTE) Whole Dried Shrimp and Ground Dried Shrimp are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Further, we have reviewed labels of products that you repack (Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, Textured Soybeans, Ground Cumin, and Whole Bay Leaves) and found serious violations of the Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). These violations cause these products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below. You may find the Act and FDA’s regulations through links in FDA's home page at www.fda.gov.External Link Disclaimer
At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, Inspectional Observations, listing the violations found at your firm. To date, we have not received a response to the inspectional observations listed on the Form FDA-483.
Your serious violations were as follows:
Seafood HACCP:
1) You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s Seafood HACCP plan for shelf stable RTE Whole Dried Shrimp and Ground Dried Shrimp products do not list the food safety hazard of allergens. Shrimp is a known allergen. Additionally, your firm does not have an allergen program.
2) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Your firm did not take a corrective action to control sulfiting agents when your process for RTE Whole Dried Shrimp deviated from your critical limit at the receiving product critical control point. Your firm’s Seafood HACCP plan identifies sulfiting agents as significant hazard at a receiving product step. The Critical Limits for each Preventive Measure states, “Incoming lots of RTE Whole Dried Shrimp must be accompanied by a lot by lot certificate stating sulfating agents were not used.” Your firm’s management provided “(b)(4) Specification Sheet” as a lot certificate which states, “May or May Not Contain Sulfites”. According to your Seafood HACCP plan, the corrective action when a deviation from a critical limit occur is to “Test the Lots for sulfiting agents. Reject the lot if (b)(4) ppm or greater.” Your firm was unable to provide testing results for sulfiting agents during the inspection.
Misbranded Foods
3) Your products Ground Dried Shrimp, Whole Dried Shrimp, Sesame Seeds, and Textured Soybeans are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because their labels fail to bear nutrition information (e.g. Nutrition Facts labels), as required by 21 CFR 101.9.
4) Your Ground Dried Shrimp, Whole Dried Shrimp, Ground Cumin, Whole Bay Leaves, Sesame Seeds, and Textured Soybeans products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages as required by 21 CFR 101.15(c)(2). For example, “net weight” or “net wt.” must be declared in both languages, and the Ground Dried Shrimp, Whole Dried Shrimp, and Textured Soybeans labels lack an ingredient statement in the foreign language.
5) Your Ground Dried Shrimp product is misbranded under sections 403(k) and 403(i)(2) of the Act [21 U.S.C. §§ 343(k) and 343(i)(2)] because the product contains artificial coloring and fails to bear labeling stating that fact. Your supplier’s specification sheet for the bulk dried shrimp states that it contains FD&C Red #40 Lake. However, your finished product label for the Ground Dried Shrimp product does not declare color additive FD&C Red No. 40 Lake as required by 21 CFR 101.22(k)(1) and 21 CFR 101.4(s).
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations cited in this letter. Failure to so may result in legal action, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comments:
You must establish and maintain records that document your employees received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene as appropriate to the food, the facility and the individual’s assigned duties, as required by 21 CFR 117.4(d).
Your firm may qualify for exemptions from nutrition labeling for certain products. We recommend you review the exemptions in 21 CFR 101.9(j). One exemption, for low-volume products, applies if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. To qualify for this exemption the person must file a notice annually with FDA. Note that low volume products that bear nutrition claims do not qualify for an exemption of this type. See https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption for additional information.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the timeframe within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: René R. Ramirez, Compliance Officer, at 1201 Main Street, Ste. 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Ramirez at (210) 308-1425 or rene.ramirez@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
Program Division Director HAF West 3
Dallas District Director
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