# Biologics, cells and tissue warning letters: 29 Updated October 13, 2026. FDA issued 29 warning letters on biologics, cells and tissue from December 16, 2024 to October 13, 2026, to 29 companies; 3 have a closeout letter. The newest, issued October 13, 2026 by the Center for Biologics Evaluation and Research, went to Calibrate IV Hydration (Unapproved New Drugs/Unlicensed Biological Product Violations). ## The full list FDA warning letters: biologics, cells and tissue: 29 rows for $5, FDA warning letters issued November 12, 2024 to October 30, 2026. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. The new rows each week by email, about 1 row a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, subject group, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email. Buy: https://specstream.ai/data/fda-warning-letters/subject/biologics-and-tissue SpecStream is the live web data engine for teams and agents. It reads FDA's warning letters table each morning, and this page is that reading. Ask for the offices, subjects or companies you follow and each new letter arrives in your sheet, CRM, Slack or agent as FDA posts it. - Letters: 29 - With closeout: 3 - Latest issued: October 13, 2026 ## Newest letters The newest 29 of 29 by issue date, each linked to the letter on fda.gov. | Issued | Company | Issuing office | Subject | Posted | Source | | --- | --- | --- | --- | --- | --- | | October 13, 2026 | Calibrate IV Hydration | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/calibrate-iv-hydration-729846-10132026) | | September 25, 2026 | Beaute Bounty | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/beaute-bounty-729163-09252026) | | September 11, 2026 | NexCell Scientific Inc | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nexcell-scientific-inc-730612-09112026) | | August 14, 2026 | R3 Medical Companies | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | August 25, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/r3-medical-companies-726330-08142026) | | June 22, 2026 | Genzyme Ireland Limited | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genzyme-ireland-limited-728681-06222026) | | May 26, 2026 | Blue Horizon International, LLC | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | June 2, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-horizon-international-llc-728085-05262026) | | February 11, 2026 | Dynamic Stem Cell Therapy | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-stem-cell-therapy-712579-02112026) | | January 29, 2026 | Central Coast Multispecialty Medical Group, Inc. | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/central-coast-multispecialty-medical-group-inc-722521-01292026) | | January 27, 2026 | Conceive Fertility Center | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/conceive-fertility-center-722459-01272026) | | January 23, 2026 | Louisville Reproductive Center | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/louisville-reproductive-center-722350-01232026) | | December 3, 2025 | Microvascular Tissue, Inc. | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/microvascular-tissue-inc-710860-12032025) | | December 3, 2025 | Green Valley Fertility Partners | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | December 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-valley-fertility-partners-720249-12032025) | | December 1, 2025 | Celularity, Inc | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celularity-inc-681480-12012025) | | December 1, 2025 | BioXtek LLC | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bioxtek-llc-715478-12012025) | | November 25, 2025 | Lux Therapeutics LLC dba Ponya Therapeutics LLC | Office of Compliance and Biologics Quality | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lux-therapeutics-llc-dba-ponya-therapeutics-llc-720001-11252025) | | September 30, 2025 | Allovate Therapeutics, LLC | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | October 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allovate-therapeutics-llc-708912-09302025) | | September 24, 2025 | New Life Medical Services, LLC | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | October 7, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-life-medical-services-llc-711102-09242025) | | September 12, 2025 | Cellebration LLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | September 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cellebration-llc-713252-09122025) | | September 9, 2025 | CSL Behring | Center for Biologics Evaluation and Research | Advertising & Promotional Labeling/Drugs/Biological Products | September 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/csl-behring-716297-09092025) | | September 4, 2025 | NuVida Medical LLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | September 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuvida-medical-llc-707745-09042025) | | August 15, 2025 | Platinum Biologics LLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-biologics-llc-705090-08152025) | | August 15, 2025 | Innate Healthcare Institute | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innate-healthcare-institute-695592-08152025) | | June 13, 2025 | InVia Fertility Specialists, PLLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | July 1, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/invia-fertility-specialists-pllc-710632-06132025) | | March 10, 2025 | MG Infusions | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | March 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mg-infusions-696890-03102025) | | February 14, 2025 | Sperm Bank, Inc. dba Fertility Center of California | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | February 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sperm-bank-inc-dba-fertility-center-california-694273-02142025) | | January 17, 2025 | BioStem Life Sciences | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | February 4, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biostem-life-sciences-673788-01172025) | | January 17, 2025 | Chara Biologics, Inc. | Center for Biologics Evaluation and Research | CGMP/Deviations/Biologics License Application (BLA) | January 28, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chara-biologics-inc-698004-01172025) | | December 30, 2024 | Evolutionary Biologics Inc. | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | January 28, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolutionary-biologics-inc-681586-12302024) | | December 16, 2024 | Skye Biologics Holdings LLC | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | May 20, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/skye-biologics-holdings-llc-654466-12162024) | ## Subjects as FDA words them | Subject | Letters | Latest | | --- | --- | --- | | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | 13 | January 29, 2026 | | Unapproved New Drugs/Unlicensed Biological Product Violations | 6 | October 13, 2026 | | CGMP/Deviations/Biologics License Application (BLA) | 6 | June 22, 2026 | | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) | 3 | December 1, 2025 | | Advertising & Promotional Labeling/Drugs/Biological Products | 1 | September 9, 2025 | ## By issuing office | Issuing office | Letters | Latest | | --- | --- | --- | | [Center for Biologics Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-biologics-evaluation-and-research) | 26 | October 13, 2026 | | Office of Compliance and Biologics Quality | 3 | December 1, 2025 | ## By year issued | Year | Letters | Latest | | --- | --- | --- | | [2025](https://specstream.ai/data/fda-warning-letters/year/2025) | 17 | December 3, 2025 | | [2026](https://specstream.ai/data/fda-warning-letters/year/2026) | 10 | October 13, 2026 | | [2024](https://specstream.ai/data/fda-warning-letters/year/2024) | 2 | December 30, 2024 | ## Where FDA publishes its warning letters - [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later. Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).