The Warning Letter states the obvious about shipping contaminated product to the US, and then provides suggestions on the company's corrective action.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/austrofood-sas-679052-08092024
WARNING LETTER
AUSTROFOOD S.A.S.
MARCS-CMS 679052 — August 09, 2024
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/austrofood-sas-679052-08092024
WARNING LETTER
AUSTROFOOD S.A.S.
MARCS-CMS 679052 — August 09, 2024
Recipient:
Francisco Jose Peña Cordovez
President
AUSTROFOOD S.A.S.
Av. General Enriquez, Tanicuchi Lote 8
171104 Quito, Pichincha
Ecuador
francisco@wanabanafruits.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
August 9, 2024
WARNING LETTER
Reference #679052
Dear Mr. Peña:
Beginning in October 2023, the U.S. Food and Drug Administration (FDA or we), along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated elevated levels of lead linked to consumption of apple cinnamon fruit puree pouches manufactured at your facility. As described below, laboratory analysis of multiple lots of your apple cinnamon fruit puree pouches detected extremely high concentrations of lead. The presence of these levels of lead causes these products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. The introduction or delivery for introduction into interstate commerce of adulterated food is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. On October 29, 2023, WanaBana USA LLC recalled 39 lots of apple cinnamon fruit puree manufactured by your firm, representing 2,998,088 individual units distributed between November 22, 2022, and October 26, 2023.
In response to this 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 at your facility, FDA inspected your ready-to-eat (RTE) acidified and acid food fruit pulp and puree product manufacturing facility, located at Av. General Enriquez, Tanicuchi Lote 8, Quito, Pichincha, Ecuador, from December 4 through December 14, 2023. During the inspection of your facility, FDA investigators found serious violation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117) and the Act. The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. We received your responses to the FDA-483 on January 8, 2024, and April 2, 2024, describing corrective actions taken and planned by your firm, and address your responses below.
Adulterated Food: Section 402(a)(1) of the Act
In October 2023, FDA was made aware of an investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana Apple Cinnamon Fruit Puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana Apple Cinnamon Fruit Puree pouches, detecting extremely high concentrations of lead. FDA reviewed and supported NCDHHS’s analytical findings.
In addition, FDA and state partners also collected and analyzed additional product samples of fruit puree and applesauce pouches manufactured by your firm. FDA, the Maryland Department of Health (MDH), the NCDA&CS, and the Pennsylvania Department of Agriculture (PDA) detected extremely high concentrations of lead in WanaBana Apple Cinnamon Fruit Puree pouches and Weis Cinnamon Apple Sauce pouches manufactured by your firm. FDA has reviewed and supports the MDH, NCDA&CS, and PDA analytical findings. Specifically:
2.18 parts per million (ppm) lead was detected in FDA Sample 1234871, 6.43 ppm lead was detected in MDH Sample FC2400004901, and 2.16 - 3.19 ppm lead was detected in NCDA&CS Samples FDC0222755 - FDC0222760 of WanaBana Apple Cinnamon Fruit Puree pouches collected from Dollar Tree stores; and 1.44 ppm lead was detected in PDA Sample F2300877-1 of Weis Cinnamon Apple Sauce pouches collected from a Weis Markets store.
Further, through finished product testing and testing of cinnamon collected at your facility, FDA determined that the cinnamon ingredient was the source of elevated lead in the apple cinnamon fruit puree pouches.
The presence of these levels of lead causes the WanaBana Apple Cinnamon Fruit Puree and Weis Cinnamon Apple Sauce pouches, which were manufactured at your facility in Ecuador, to be adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health. Exposure to lead at the levels found in the WanaBana Apple Cinnamon Fruit Puree and Weis Cinnamon Apple Sauce pouches could result in acute lead toxicity. Lead is toxic to humans and can affect people of any age or health status; children are particularly susceptible to lead toxicity due to their low body weight. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Short term exposure to lead could result in the following symptoms: headache, abdominal pain/colic, vomiting, and anemia. Longer term exposure could result in the following additional symptoms: irritability, lethargy, fatigue, muscle aches or muscle prickling/burning, constipation, difficulty concentrating/muscular weakness, tremor, and weight loss.
Your firm caused these adulterated apple cinnamon products to be imported into the United States. The products were imported into the United States in multiple shipments. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)]. By shipping the apple cinnamon fruit puree pouches to the United States, you caused the introduction or delivery for introduction into interstate commerce of adulterated food in violation of section 301(a) of the Act.
We acknowledge that on October 29, 2023, WanaBana USA LLC recalled 39 lots of apple cinnamon fruit puree manufactured by your firm. Due to the serious public health concerns related to the sale of adulterated apple cinnamon fruit puree products that were manufactured by your facility with the lead-contaminated cinnamon, it is essential that this violation does not reoccur.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
As stated above, FDA investigators found serious violation of the CGMP & PC rule. The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
You did not appropriately conduct a hazard analysis to identify and evaluate a known or reasonably foreseeable hazard (lead) for your apple cinnamon fruit puree pouch products to determine whether that hazard (lead) required a preventive control, as required by 21 CFR 117.130(a)(1). Your hazard evaluation must consider, among other factors, the effect of raw materials and other ingredients as well as the intended and reasonably foreseeable use on the safety of the product for the intended consumer (see 21 CFR 117.130(c)(2)). You use cinnamon powder as an ingredient in your apple cinnamon fruit puree pouches, a product intended for young children, including infants as young as six months old. Lead is often found in spices, including cinnamon, and oral exposure to elevated levels of lead can pose health risks to humans, particularly children, as described above. Therefore, lead in a cinnamon ingredient is a known or reasonably foreseeable hazard for which young children are especially sensitive.
Your hazard analysis dated November 14, 2022, identified lead as a potential hazard in your raw materials generally; your evaluation, which did not consider the cinnamon ingredient in particular, concluded lead was not a hazard requiring a preventive control, listing “Analisis de metales pesados minimo (b)(4)” (analysis of heavy metals minimum (b)(4)) as the justification for this conclusion. Your hazard analysis dated September 27, 2023, identified lead as a potential hazard in the cinnamon ingredient but your evaluation determined it did not require a preventive control, listing “Proveedor sin precedentes historicos” (supplier without historical precedents) as the justification for this conclusion. Considering the known prevalence of lead in spices such as cinnamon and the intended audience of your finished product, including the particular susceptibility of young children to the negative health effects of lead exposure, a knowledgeable person at your facility manufacturing/processing foods intended for young children would identify lead in this cinnamon ingredient as a hazard requiring a preventive control.
A receiving facility that identifies raw materials and other ingredients with a hazard requiring a supply-chain-applied control, such as lead, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers, determining appropriate supplier verification activities (including determining the frequency of conducting the activity), and conducting supplier verification activities (see 21 CFR 117.410).
Although the two hazard analyses referenced above did not identify lead in your cinnamon ingredient as a hazard requiring a preventive control, these hazard analyses nonetheless listed purchasing from an approved supplier and receiving certificates of analysis (COAs)/lab results from the supplier as controls for lead. In addition, we acknowledge that you had a written supply-chain program in place. Your supply-chain program covered Negasmart, the third-party distribution company from whom you obtained the ground cinnamon used in the recalled apple cinnamon fruit puree pouches manufactured at your facility. However, your activities involving Negasmart show that you did not implement the provision in your supply-chain program requiring onsite audits of suppliers located in Ecuador to be performed at least once per year. In particular, you informed our investigators that an onsite audit was not conducted of Negasmart (the entity which you approved as your supplier). Instead, you conducted a “desk audit” of Negasmart that was not consistent with your supply-chain program.1
We acknowledge correspondence from your consultant received on January 18, 2024, describing that your facility had resumed production of apple cinnamon fruit puree products using a new cinnamon supplier, and advising of plans to offer product for import into the United States under a new brand. After your recall, your revised hazard analysis dated November 15, 2023, identified presence of heavy metals in cinnamon as a hazard requiring a supply-chain control, with the rationale that there may be intentional contamination. Similarly, your revised hazard analysis dated March 5, 2024 (which you provided in your April 2, 2024, response) identifies presence of heavy metals and inclusion of prohibited substances (lead, chrome) in cinnamon as hazards requiring supply-chain controls, with the rationale that there may be intentional contamination. We note that lead in dried, ground spices (and other ingredients) may also be present due to circumstances other than economically motivated adulteration. For example, previous testing of dried, ground spices at retail have detected lead at a range of levels not suggestive of intentional adulteration. Because lead can accumulate in the body, even lower-level chronic exposure can be hazardous over time. A chemical hazard may cause immediate effects or may be associated with potential long-term effects after chronic exposure to the chemical. Your response received April 2, 2024, also includes your revised supply-chain program dated March 5, 2024, which identifies a new supplier you approved for cinnamon powder. We will assess the adequacy of your corrective actions during the next inspection.
In addition to the violations described above, we offer the following comments:
1. After your recall, your supply-chain program for heavy metals in cinnamon powder dated March 5, 2024, describes that a representative sample of each batch received from your approved supplier will now be tested by an external laboratory to verify the levels of heavy metals reported in the supplier’s quality certificate (certificate of analysis or COA). The procedure describes that if lead is detected above permitted limits, the batch will be blocked, the supplier will be informed, and the ingredient will be returned and/or destroyed. Another entity may conduct the supplier verification activities; however, as the receiving facility, 21 CFR 117.415(a)(3) requires that you document your review and assessment of the entity’s applicable documentation, such as a COA. FDA recommends that a COA document that major analytical parameters for the specific food, or lots, contained in a specific shipment have been met. The laboratory conducting the testing should use scientifically valid laboratory methods and procedures that can provide reliable, accurate test results.
After your recall, your response received April 2, 2024, includes your “Heavy Metal Monitoring Program in Finished Products” procedure dated March 8, 2024. The procedure describes plans to have an external laboratory test each batch of both the apple cinnamon puree product and the cinnamon powder for lead, and your established specification is (b)(4) ppb lead for both the finished product and the cinnamon ingredient. The procedure does not describe what will constitute a representative sample, the analytical method that will be used by the external laboratory, or assurances that the analytical method will be followed. You have not provided evidence of implementation of this sampling.
Stringent verification activities for heavy metals in cinnamon powder should be established and implemented to ensure your finished product is not adulterated, especially when considering that the intended consumer of your apple cinnamon fruit puree pouches includes a more susceptible population of infants and young children. Additional finished product testing may help assess and verify the effectiveness of your food safety plan.
2. During the inspection, FDA collected samples of cinnamon powder that you received from Negasmart (represented by FDA Samples 1085090 and 1085091). In addition to FDA analysis revealing extremely high levels of lead, at 5,110 ppm and 2,270 ppm, FDA analysis revealed extremely high levels of chromium, at 1,201 ppm and 531 ppm. Based on additional analyses, FDA determined that lead chromate was also present in the sampled cinnamon powder. Lead chromate in the cinnamon powder is indicative of economic adulteration.
When conducting your hazard analysis, you must consider known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain (i.e., economically motivated adulteration) (see 21 CFR 117.130(b)(2)(iii)). There have now been several occurrences of lead compounds (e.g., lead chromate and lead oxide) that have appeared to be intentionally added to spices (e.g., turmeric, paprika, and cinnamon powder) that have caused illness and/or death, including the occurrence at your facility. Considering the pattern of economically motivated adulteration in the past, we expect that a knowledgeable person at your facility making foods intended for young children would conclude that hazards that may be intentionally introduced for economic gain (such as lead in dried ground spices) will need preventive controls (e.g., supply chain controls). We acknowledge that your updated hazard analysis, dated March 5, 2024, concludes that lead that may be intentionally introduced in cinnamon will need preventive controls. Further, when establishing verification activities for a hazard that may be intentionally introduced to a raw material or other ingredient, we expect that a knowledgeable person at your facility making foods intended for young children would consider conducting their own testing to verify levels in the raw material or other ingredient and/or to verify testing results provided by the supplier. We acknowledge that your “Heavy Metal Monitoring Program in Finished Products” procedure dated March 8, 2024, describes plans to have an external laboratory test each batch of both the apple cinnamon puree product and the cinnamon powder for lead; please see our comments above regarding this.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct the deviation, including an explanation of how your firm plans to prevent the violation or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If you believe that your facility or your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
You should direct your written reply to CFSANEnforcement@fda.hhs.gov, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact CFSAN via email at CFSANEnforcement@fda.hhs.gov. Please reference CMS #679052 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
___________________
1 We acknowledge that at the time you were sourcing your cinnamon ingredient from Negasmart, FDA had issued a guidance document entitled, “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID–19 Public Health Emergency.” The guidance communicates the Agency's intention not to enforce certain onsite audit requirements in the preventive controls regulation (as well as certain other regulations) in certain circumstances, which are not present in your case.
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