FDA warns companies about lead contamination and other violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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The FDA has issued warning letters to four companies for failing to comply with federal food safety regulations. The letters, stemming from inspections and investigations into significant hazards, outline deficiencies in compliance with the Foreign Supplier Verification Program (FSVP). 

WanaBana USA LLC
Jacksonville, FL

The FDA sent a warning letter to WanaBana USA LLC on Nov. 4, 2024, following inspections conducted from Feb. 21 to March 7, 2024. The inspections were prompted by a recall of WanaBana Apple Cinnamon Fruit Puree pouches due to lead contamination. Some samples contained lead levels as high as 6.43 ppm, posing a severe health risk, particularly to infants.

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 the company’s foreign supplier Austrofood S.A.S. (Austrofood) of Ecuador. Apple cinnamon fruit puree pouches were subject to a Class 1 recall, initiated on Oct. 29, 2023. The recall was in response to finished product samples of Wanabana brand RTE apple cinnamon fruit puree packed in flexible pouches, collected by North Carolina Department of Health and Human Services (NCDHHS) found to contain extremely high concentrations of lead. You imported WanaBana brand apple cinnamon fruit puree pouches from your foreign supplier, Austrofood. The FDA placed apple cinnamon fruit puree pouches from Wanabana’s foreign supplier on Import Alert #99-42, “Detention Without Physical Examination (DWPE) of Foods Due to Heavy Metal (Toxic Element) Contamination,” on Nov. 6, 2023.

FDA and state partners also collected and analyzed additional product samples of fruit puree and apple sauce pouches manufactured by your foreign supplier Austrofood. FDA, the Maryland Department of Health (MDH), and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) detected extremely high concentrations of lead in WanaBana Apple Cinnamon Fruit Puree pouches imported by your firm.

The FDA found WanaBana failed to adequately evaluate hazards like heavy metals, lacked proper supplier verification activities, and did not implement corrective actions to prevent recurrence. The company was instructed to revise its FSVP to ensure compliance.

The full warning letter can be found here.

Purcell International
Pleasant Hill, CA

Purcell International received a warning letter on Nov. 5, 2024, after FDA inspections revealed significant FSVP violations. The inspections tied the violations to a multistate investigation into lead contamination in apple cinnamon products. The inspections took place on Feb. 28, 29, and March 6, 2024, after elevated lead levels were detected in fruit puree pouches.

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. 

The FDA determined Purcell’s supplier verification activities, such as third-party audits and sampling, were inadequate to detect or prevent lead contamination. The FDA also noted the company failed to take corrective actions or modify its FSVP in response to the contamination. The products were subsequently placed on an import alert for toxic element contamination.

The full warning letter can be found here.

Caribbean Produce Exchange LLC
Catano, Puerto Rico

The FDA issued a warning letter to Caribbean Produce Exchange LLC on Nov. 4, 2024, after inspections conducted from Feb. 27 to March 6, 2024, revealed failures to comply with FSVP regulations. The inspections were linked to products, including fruit puree pouches, containing elevated lead levels.

The FDA found Caribbean Produce failed to conduct hazard analyses, provide adequate verification activities, or reevaluate its foreign suppliers in light of the contamination. The agency emphasized the company’s systemic failures to prevent contaminated products from entering the U.S. market.

The full warning letter can be found here.

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Source: https://www.foodsafetynews.com/2025/01/fda-warns-companies-about-lead-contamination-and-other-violations/