# FDA WARNING_LETTER - Abbott Laboratories - October 24, 2023

Source: https://www.globalkeysolutions.net/records/warning_letter/abbott-laboratories/d12e62ee-cedb-439c-bd11-4cb7ceb1ad64

> FDA WARNING_LETTER for Abbott Laboratories on October 24, 2023. Product: Biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Abbott Laboratories
- Inspection Date: 2023-10-24
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA issued Warning Letter #669353 to Abbott on October 24, 2023, following a review of their websites (www.abbottnutrition.com, www.abbott.com, www.pediatricproconnect.com) and marketing materials for Similac® Probiotic Tri-Blend (Similac Probiotic Supplement) in October 2023.

The FDA identified several violations:
1.  **Unapproved New Drug and Unlicensed Biological Product:** Similac Probiotic Supplement, containing *Bifidobacterium infantis* (Bb-02) and *Streptococcus thermophilus* (TH-4®) and marketed for preterm infants, is deemed an unapproved new drug and unlicensed biological product. Marketing materials and website statements claim the product "significantly improve outcomes" for "All-cause mortality," "Necrotizing enterocolitis (NEC)," "Late-onset sepsis," and "Feeding tolerance," indicating intended use for disease mitigation, treatment, or prevention. This violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(d)] and the Public Health Service Act (PHS Act) [42 U.S.C. § 262(a)(1)]. A valid biologics license application (BLA) or investigational new drug application (IND) is

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)
- [Director](https://www.globalkeysolutions.net/people/melissa-j-mendoza/681d7777-4f19-4ecc-b31d-3272cb275c77)

Company: https://www.globalkeysolutions.net/companies/abbott-laboratories/4058c1e7-dbe8-4b13-bcb0-de12343cd685

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d