Productos Carey, Inc.

WARNING LETTER Productos Carey, Inc. MARCS-CMS 606229 — June 10, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Food & Beverages Recipient: Recipient Name Mr. Carlos Reynoso Recipient Title CEO Productos Carey, Inc. 5340 Lindbergh Lane Bell , CA 90201-6415 United States Issuing Office: Division of West Coast Imports United States June 10, 2020 WARNING LETTER Re: CMS # 606229 Dear Mr. Reynoso, On February 4, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Productos Carey, Inc. 5340 Lindbergh Lane, Bell, CA 90201. We also conducted an inspection on September 18, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals . During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, Crushed Tomatillo and Green Mexican Sauce, all imported from Productos Carey SA de CV, Calle Guadalajara Ameca Km. 10 Tala, Mexico. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection, and the follow-up inspection on February 4, 2020, our investigator provided you in each instance with a Form 483a, FSVP Observations. We acknowledge receipt of your response dated February 10, 2020 which included a letter and attachments. In your response letter you stated you will “develop voluntarily a full FSVP plan” and that you “requested from [your] supplier, Productos Carey in Mexico the hazard analysis for ‘all’ (each and every one) the products that [you] import from Mexico.” You submitted a copy of registration for FSVP training April 16-17, 2020. However, we are unable to evaluate the adequacy of your response because you did not provide details or timeframes as to when you will complete and implement these actions. You also submitted proof of registration of your warehouse. We also acknowledge that on September 20, 2018, in response to our initial inspection, your firm submitted via email, your foreign supplier’s hazard analyses for Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce and Crushed Tomatillo, which were provided again during the most recent inspection. Your significant violations of the FSVP regulation are as follows: 1. For the Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, Crushed Tomatillo, and Green Mexican Sauce from your foreign supplier Productos Carey SA de CV, Mexico, you did not meet the requirement to conduct a hazard analysis in accordance with 21 CFR 1.504. You may meet the requirement by reviewing and assessing your foreign supplier’s hazard analysis and documenting your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During our inspection, you provided copies of your foreign supplier’s hazard analyses for Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, and Crushed Tomatillo. As far as you rely on these hazard analyses to meet your obligations under the FSVP regulation, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazard analyses, as required by 21 CFR 1.504(d). You did not provide a hazard analysis for the Green Mexican Sauce. 2. You did not conduct and document one or more of the foreign supplier verification activities with respect to the foods you import, as required by 21 CFR 1.506(e). Your Standard Operating Procedures (SOP) with respect to “External Audits” and SQF audit certificate for Productos Carey SA de CV provided during the inspection do not indicate there was consideration for the FDA food safety regulations applicable to the food you import, specifically 21 CFR parts 117 and 113, or a review of the supplier's written food safety plan and its implementation for the hazards being controlled. The one-page SQF audit certificate lists several product descriptions and states the scope of the audit as “Canning, UHT and Aseptic Operations,” but does not include audit procedures or refer to FDA regulations. 3. In addition, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113. For the Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, Crushed Tomatillo, and Green Mexican Sauce, you did not verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L. You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of Sliced Carrots in Brine, Chipotle Peppers Whole in Adobo Sauce, Crushed Tomatillo and Green Mexican Sauce imported from Productos Carey SA de CV, Calle Guadalajara Ameca Km. 10 Tala, Mexico. We may place the foods from the identified foreign supplier on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html . In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Please send your reply to Food and Drug Administration, Attention: Courtney Warren, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Compliance Officer, Courtney Warren via email at Courtney.Warren@fda.hhs.gov. Please reference CMS # 606229 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us. Sincerely, /S/ Dan Solis Program Division Director Division of West Coast Imports Content current as of: 06/16/2020 Regulated Product(s) Food & Beverages