FDA WARNING_LETTER - SUPERCAN BULLY STICKS LLC - May 22, 2025

The FDA issued a Warning Letter to Supercan Bully Sticks LLC on September 24, 2025, following inspections conducted from April 17-23, 2025, and April 21-May 22, 2025. These inspections were prompted by a March 28, 2025, Class 1 recall of the firm"s Pig Ear Slivers pet treats due to Salmonella enterica contamination, leading to adulterated products. Major violations include the company"s failure to develop and implement a Foreign Supplier Verification Program (FSVP) for imported animal food products, as required by Section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR Part 1, Subpart L. Additionally, Supercan Bully Sticks LLC failed to prepare and implement a written food safety plan, including a hazard analysis and other preventive controls, violating 21 CFR Part 507 for Current Good Manufacturing Practice and Risk-Based Preventive Controls for Food for Animals. Other issues included the use of unapproved color additives, failure to register the facility, and non-compliance with Reportable Food Registry requirements. Supercan Bully Sticks LLC must respond within fifteen working days, detailing specific corrective actions to address these violations and prevent recurrence. Failure to comply may lead to legal actions such as product seizure, injunctions, and refusal of admission for imported goods.