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  1. Warning Letters

WARNING LETTER

Purcell International MARCS-CMS 680631 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Colleen D. Purcell-Kangas
Recipient Title
President
Purcell International

800 Ellinwood Way
Pleasant Hill, CA 94523-4703
United States

Issuing Office:
Division of West Coast Imports

United States

Secondary Issuing Offices

United States

December 9, 2024

Warning Letter

Dear Ms. Purcell-Kangas:

On February 28, February 29, and March 6, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Purcell International, 800 Ellinwood Way, Pleasant Hill, CA 94523-4703. This inspection was 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 inspection was initiated in response to a multistate investigation involving elevated levels of lead in apple cinnamon fruit puree pouches (intended for infants as young as six months and the general public), manufactured by your foreign supplier Austrofood S.A.S. (Austrofood) of Ecuador. Apple cinnamon fruit puree pouches were subject to a Class 1 recall, initiated on October 29, 2023. The recall was in response to finished product samples of WanaBana brand ready-to-eat (RTE) apple cinnamon fruit puree packed in
flexible pouches, collected by North Carolina Department of Health and Human Services (NCDHHS), that were found to contain extremely high concentrations of lead; the recall was expanded to include Schnucks and Weis brand cinnamon apple sauce. You imported the Schnucks and Weis brand Apple Sauce – Apple Cinnamon (cinnamon apple sauce) from your foreign supplier, Austrofood. We placed apple cinnamon fruit puree pouches from your foreign supplier on Import Alert #99-42, “Detention Without Physical Examination (DWPE) of Foods Due to Heavy Metal (Toxic Element) Contamination,” on November 6, 2023. You may view this alert at: https://www.accessdata.fda.gov/cms_ia/importalert_1167.html.

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 the foods you import. Because of these significant violations, your firm is not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We received your response to the FDA 483a, on March 29, 2024, describing corrective actions taken and planned by your firm and we address your response below.

Your significant violations of the FSVP regulations are as follows:

1. Your foreign supplier verification activities did not provide adequate assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). Specifically, you told our investigator that before the recall, you determined your verification activity for cinnamon apple sauce from Austrofood is (b)(4) third- party audit (onsite audit), in accordance with 21 CFR 1.506(e)(1)(i). We note that your determination, including the frequency with which the activity must be conducted, was not documented, as required by 21 CFR 1.506(d)(1)(i). Further, records of the onsite audits you provided, conducted before the recall in (b)(4) and (b)(4), did not address your supplier’s control of heavy metals, specifically lead, in cinnamon apple sauce. For example, the (b)(4) audit lists chemical hazard (heavy metals) as one of the hazards assessed by your supplier; however, controls for heavy metals were not addressed in the audit. The October 2023 audit mentions the technical sheet for ground cinnamon was reviewed; however, specifications or hazards associated with ground cinnamon were not addressed in the audit. The October 2023 audit states HACCP plans for fruit and vegetable purees packed in pouches were reviewed; however, the audit does not address whether heavy metals in cinnamon apple sauce was controlled.

Additionally, you told our investigator that in past shipments, external laboratory testing was used to verify lead levels in final product. In accordance with 21 CFR 1.506(d)(1)(ii)(B), you may determine sampling and testing of a food is an appropriate verification activity. You provided records of one occurrence of sampling and testing of the finished product of cinnamon apple sauce by a laboratory (b)(4) contracted by your supplier. The results you provided of the testing conducted in June 2023 of lot “05023:19 / 05023:28” detected less than 0.08 mg/kg (0.08 ppm) lead. However, after you imported product into the United States, (b)(4) sampled and tested (b)(4) cinnamon apple sauce, lot “(b)(4)” and detected 1.44 ppm lead. The products analyzed by (b)(4) are from the same batch codes of cinnamon apple sauce that were recalled due to elevated levels of lead. The FDA reviewed and supports PDA’s analytical findings.

We acknowledge that you told our investigator that the discrepancy in analytical findings informed your plans to perform lab analysis of all lots of food imported from the supplier, including products that do not contain cinnamon, for a period of (b)(4), utilizing a third-party laboratory within the United States. We note that your determination of a verification activity, including the frequency with which the activity must be conducted, must be documented, as required by 21 CFR 1.506(d)(1)(i). We will verify your planned corrective actions at the next inspection.

As described above, the verification activities you conducted failed to provide assurance that the hazards requiring a control, specifically the chemical hazard of heavy metals in the cinnamon apple sauce products you import, have been significantly minimized or prevented, as required by 21 CFR 1.506(c).

Furthermore, per 21 CFR 1.506(e)(3), you must promptly review and assess the results of the verification activities that you conduct and document your review and assessment of the results of the verification activities. If the results do not provide adequate assurances that the hazards requiring a control in the food you obtain from the foreign supplier have been significantly minimized or prevented, you must take appropriate action in accordance with 21 CFR 1.508(a).

2. You did not document that you promptly reevaluated a foreign supplier’s performance or the risk posed by a food when you became aware of new information about the foreign supplier’s performance or the risk posed by a food, as required by 21 CFR 1.505(c)(1). Specifically, our inspection found that you did not document that you promptly reevaluated your foreign supplier’s performance or the risk posed by a food when you became aware of the elevated levels of lead detected in the cinnamon apple sauce products you imported from (b)(4). At the inspection you were unable to provide documentation of your reevaluation of Austrofood's performance or the risk posed by the cinnamon apple sauce product you import. You told the FDA investigator that you did not have any documents or updates to your FSVP in response to the lead contamination event.

3. You did not promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP after you determined that your foreign supplier produced food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act, in accordance with 21 CFR 1.508(b). If you determine that a foreign supplier of food that you import does not produce food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act, you must promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP, in accordance with 21 CFR 1.508(b). You must document any investigations, corrective actions, and changes to your FSVP that you undertake. Specifically, during our inspection you were unable to provide documentation of corrective actions and changes to your FSVP for the cinnamon apple sauce product imported from Austrofood after you determined this product from Austrofood was contaminated with lead and product was recalled.

Further, on March 5, 2024, you offered for import into the United States apple cinnamon fruit puree product, from the same foreign supplier under a new brand, without having documented corrective actions or changes to your FSVP for this foreign supplier, in accordance with 21 CFR 1.508(b).

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 address the above violations. If you do not promptly address 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 the cinnamon apple sauce imported from your foreign supplier Austrofood. We may place the food you import from the identified foreign supplier on DWPE when you import the product. You can find DWPE information relating to FSVP in Import Alert #99-41, “Detention Without Physical Examination (DWPE) of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation,” 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 any 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 FSVPs, 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 you 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 working 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: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 680631 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.


Sincerely,
Digitally signed by Lawton W.
Lawton W. Lum -S Lum -S
Date: 2024.11.05 15:07:25 -08'00'
for
Dr. Kathleen Turner Program Division Director
Division of West Coast Imports

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