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  5. Abbott Laboratories - 669353 - 12/12/2024
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CLOSEOUT LETTER

Abbott Laboratories MARCS-CMS 669353 —

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

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