Pharma & Drug Safety

FDA Draft Guidance on 3-Year Exclusivity for Drug Products

The FDA has issued draft guidance to assist applicants requesting 3-year exclusivity for drug products. The guidance, available for public comment, clarifies the statutory and regulatory criteria for eligibility and provides recommendations on request content and format. This aims to support the Drug Competition Action Plan.

FDA Warning Letter to Diasol, Inc. for Medical Device Violations

The FDA issued a warning letter to Diasol, Inc. for manufacturing unapproved and misbranded medical devices, specifically disinfectants for hemodialysis systems. The company also violated Quality System Regulation requirements. The FDA has requested corrective actions to ensure compliance.

FDA Warning Letter to Beta Bionics, Inc.

The FDA issued a warning letter to Beta Bionics, Inc. regarding violations of the Quality System Regulation for their iLet Dosing Decision Software and iLet ACE Pump. The letter details failures in corrective and preventive action procedures, including inadequate analysis of complaints leading to serious adverse health outcomes.

FDA Warning Letter to Kare Solutions LLC dba Zappy

The FDA issued a warning letter to Kare Solutions LLC dba Zappy for misbranding compounded drug products, including semaglutide, tirzepatide, and liraglutide. The agency found that Zappy's website made false or misleading claims about these products, suggesting they were FDA-approved or compounded by Zappy when they were not.

FDA Warning Letter to Strut Health, LLC

The FDA issued a warning letter to Strut Health, LLC on February 20, 2026, for misbranding compounded semaglutide and tirzepatide products. The company's website allegedly made false or misleading claims about these drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to GenoGenix LLC

The FDA issued a warning letter to GenoGenix LLC for serious deficiencies in drug production practices, including failures to meet conditions for outsourcing facilities and insanitary conditions. The company has ceased production and initiated a voluntary recall of drug products.

FDA Warning Letter to Supercan Bully Sticks LLC

The FDA issued a warning letter to Supercan Bully Sticks LLC on September 24, 2025, following inspections that revealed serious violations of the Foreign Supplier Verification Program (FSVP) and Current Good Manufacturing Practice regulations. These violations were identified after a voluntary recall of pet treats due to Salmonella contamination.

FDA Warning Letter to Black Sheep Egg Company

The FDA issued a warning letter to Black Sheep Egg Company, LLC, following an inspection that detected Salmonella in environmental samples from their shell egg processing facility. The company is cited for insanitary conditions and violations of the Shell Egg regulation, rendering their products adulterated.

FDA Warning Letter to The Father's Table, LLC

The FDA issued a warning letter to The Father's Table, LLC, for serious violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food regulations. The inspection found Listeria monocytogenes in the facility, rendering ready-to-eat food products adulterated.

FDA Warning Letter to John Yoder Farm

The FDA issued a warning letter to John Yoder Farm for serious violations of the Shell Egg Regulation (21 CFR Part 118) and the FD&C Act. The farm failed to implement a written Salmonella Enteritidis Prevention Plan and had other insanitary conditions. The FDA is concerned about the compliance status and potential health risks.