The FDA said Walgreens has addressed violations related to drug listing deficiencies for one of its products, according to a Dec. 19 close-out letter.
The agency previously cited Walgreens in September 2023 for discrepancies in the electronic listing file of Walgreens Sensitive Extra Whitening (NDC 0363-1588), including inconsistencies in active ingredient information and strength values submitted to the FDA. The issues rendered the product misbranded under federal law.
Following the company’s corrective actions, the FDA’s Center for Drug Evaluation and Research said the deficiencies appear to have been resolved. However, the agency said it will continue to assess the adequacy and sustainability of the corrections in future regulatory activities.
The letter, addressed to Walgreens executive Jessica Martinez, reiterated the company’s ongoing responsibility to maintain compliance with the Federal Food, Drug, and Cosmetic Act.
