Inspections, Compliance, Enforcement, and Criminal Investigations
El Chilerito Spice Co. Inc. 9/30/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
September 30, 2011
Mr. Jorge Reyes, President
El Chilerito Spice Co. Inc.
1613 Potrero Avenue
South El Monte, CA 91733
Dear Mr. Reyes:
On January 26, 2011 through February 3, 2011, FDA conducted an inspection of your firm concurrently with a USDA-FDA joint investigation. The inspection was initiated as a result of information obtained by USDA investigators at one of your firm’s customers and covered your receiving, storage, labeling and distribution practices. Subsequent analyses of five samples of your Pimienton Chorizero spice product collected from three of your customers during the joint investigation were found to be adulterated within the meaning of section 402(c) [21 U.S.C. § 342 (c)] of the Act because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) and were found to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act in that the labeling did not contain required information.
Your Pimienton Chorizero product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because it bears or contains color additives which are unsafe within the meaning of section 721(a) of the Act. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with a color additive listing regulation. Specifically, the product contains Cochineal Red A (Ponceau 4R) and Carmoisine, neither of which are listed in FDA regulations.
Your Pimienton Chorizero product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain an artificial flavoring, coloring, or chemical preservative and do not bear labeling stating that fact. In accordance with 21 CFR 101.22(k) the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients.
Your Pimienton Chorizero product is manufactured with Sunset Yellow FCF; however, the product does not bear a label identifying the presence of this color additive. Sunset Yellow FCF is certifiable as FD&C Yellow No. 6. Under 21 CFR 101.22(k)(l ), color additives subject to certification must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 6).
Your Pimienton Chorizero product is misbranded under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product fails to bear the common or usual name of the food in accordance with 21 CFR 101.3.
Your Pimienton Chorizero is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the “Pimienton Chorizero” is fabricated from two or more ingredients, but fails to bear the common or usual name of each ingredient as specified by 21 CFR 101.4.
For ingredients that are themselves composed of two or more ingredients, (e.g., mayonnaise), the requirement to list the component ingredients (or “sub-ingredients”) may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or (2) listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
Your Pimienton Chorizero product is misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that the product fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The product is further misbranded under section 403(e)(2) because the product does not declare the net quantity of contents on the unlabeled product in accordance with 21 CFR 101.105.
This letter is not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring in the future. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
We also note that prior to the investigation that is the main subject of this letter, on June 30, 2010 an FDA Investigator visited your firm and collected shipping documents pertaining to the Chile Guajillo sent to (b)(4). Your firm informed the FDA Investigator that the remaining (b)(4) cartons of the original shipment were being held in your warehouse and would remain quarantined until further advisory from the FDA. On July 2, 2010, we obtained an isolate from the private laboratory that analyzed the Chile Guajillo shipment sent to (b)(4). This isolate was subsequently confirmed by the FDA laboratory to be Salmonella Idikan.
The Chile Guajillo that was returned by (b)(4) was received by your firm on July 12, 2010. Your firm provided a reconditioning proposal on July 15, 2010 to the Los Angeles District Office to have the entire shipment of (b)(4) cartons containing Chile Guajillo peppers treated with (b)(4). You contacted the Los Angeles District Office and informed our Compliance Branch that this shipment was being held intact. After submitting several revised proposals to address deficiencies, your proposal was eventually approved on November 5, 2010.
On November 19, 2010, an FDA Investigator examined (b)(4) cartons of chili peppers at the reconditioning facility which were identified with the original (b)(4) tags as “Guajillo (b)(4)”. However, the cartons did not match the original cartons examined by the FDA Investigator at (b)(4) and they were not marked as “Chile Guajillo”.
On November 23, 2010, an FDA Investigator visited your firm to investigate the missing product. Your firm was not able to account for the missing (b)(4) cartons of Salmonella contaminated Chile Guajillo peppers and later determined that the product had been commingled and shipped to customers. Your firm provided a distribution list accounting for all Chile Guajillo distributed by your firm after receipt of the Salmonella contaminated Chile Guajillo from (b)(4). On September 15, 2010, your firm shipped (b)(4) of Chile Guajillo to your customer (b)(4)) located in (b)(4). On December 10, 2010 your firm initiated a voluntary recall of all Chile Guajillo from (b)(4) distributed by your firm from July 8 through November 24, 2010.
A follow-up investigation was conducted at your firm on December 16, 2010. This investigation revealed that you misrepresented the (b)(4) cartons sent for reconditioning at the (b)(4) facility on November 19, 2010 as the Chile Guajillo peppers returned by (b)(4).
In your response to this warning letter, please include documentation of the corrective actions you have taken as well as steps you have taken to improve your recall system, such as warehousing practices including, but not limited to, product quarantine, as well as corrections to your labeling procedures. In addition, please inform us of the steps you have taken to verify that products you receive from your suppliers are in compliance with the Act. Again, it is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is a prohibited act under section 301(a) of the Act. Violations of Section 301 of the Act can result in civil and/or criminal penalties. Failure to prevent future violations may result in regulatory action without further notice such as seizure, injunction, detention without physical examination of shipments, debarment, and/or criminal prosecution.
Please send your reply to the Food and Drug Administration, Attention:
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Alonza E. Cruse
Los Angeles District