FDA WARNING_LETTER - Purcell International - March 06, 2024

The FDA issued a Warning Letter to Purcell International following a Foreign Supplier Verification Program (FSVP) inspection conducted in February and March 2024. The inspection was prompted by a multistate investigation into elevated lead levels in apple cinnamon fruit puree pouches, manufactured by their foreign supplier Austrofood S.A.S. of Ecuador, which led to a Class 1 recall and Import Alert #99-42. Purcell International imported the affected Schnucks and Weis brand cinnamon apple sauce. The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L). Specifically, Purcell International failed to ensure their foreign supplier verification activities adequately minimized or prevented hazards, such as heavy metals, in imported food, as required by 21 CFR 1.506(c). Their third-party audits and lab testing records did not sufficiently address lead control. The firm also failed to document prompt reevaluation of the foreign supplier's performance or the food's risk after becoming aware of the lead contamination, violating 21 CFR 1.505(c)(1). Furthermore, Purcell International did not promptly investigate and modify their FSVP after determining the imported food was adulterated, as mandated by 21 CFR 1.508(b), even offering new product from the same supplier without documented corrective actions. The FDA requires prompt corrective actions, including a written response within 15 working days detailing specific corrections and providing supporting documentation. Failure to comply may result in refusal of admission for imported products and placement on Import Alert #99-41, prohibiting further imports without a compliant FSVP.