Abbott Laboratories

CLOSEOUT LETTER Abbott Laboratories MARCS-CMS 669353 — December 12, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Biologics Recipient: Recipient Name Robert B. Ford Recipient Title CEO Abbott Laboratories 100 Abbott Park Road Abbott Park , IL 60064 United States robert.ford@abbott.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States Secondary Issuing Offices United States Dear Mr. Ford: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to Warning Letter (WL) #669353 dated 10/24/2023. Based on our evaluation, we understand you are no longer marketing Similac® Probiotic Tri-Blend; as such, it appears that you have addressed the violations contained in this WL. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. We acknowledge, based on information we received after issuance of the WL, that Bifidobacterium longum subsp. infantis DSM 33361 (BB-02) is a dietary ingredient according to section 201(ff)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). We note, however, that our evaluation also concludes that a dietary supplement containing BB-02 presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling when the product is recommended or suggested in the labeling for use by preterm infants [see sec 402(f)(1)(A) of the FD&C Act]. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Carrie Lawlor, Branch Chief Dietary Supplement Enforcement Branch Division of Critical Foods and Dietary Supplement Enforcement Office of Enforcement Office of Compliance and Enforcement Content current as of: 01/21/2025 Regulated Product(s) Biologics