FDA EIR - Lannett Company Inc. - July 23, 2018

Lannett Company Inc.'s Seymour, IN facility underwent a comprehensive FDA inspection from July 20-23, 2018. The inspection, conducted under the Dietary Supplement Import and Domestic Compliance Program (CP 7321.008), focused on the manufacturing of Sodium Chloride, USP 1,000 mg tablets. While no FDA Form 483 was issued during this inspection, two significant issues were identified. Firstly, the firm lacked a valid Food Firm Registration, a regulatory requirement for dietary supplement manufacturers. Secondly, the labeling for their Sodium Chloride tablets was deficient; it failed to include the explicit "dietary supplement" statement and omitted the mandatory disclaimer ("not intended to diagnose, treat, cure, or prevent any disease") for the structure/function claim present on the label. In response, Lannett Company management promptly initiated a quarantine of all Sodium Chloride, USP 1,000 mg tablets within their control. They further committed to discontinuing the product and developing a comprehensive exit strategy to address patient needs and potential market disruption. Management also pledged to provide a formal written response to the FDA within 15 business days, outlining their corrective actions.