Data / FDA warning letters / Biologics, cells and tissue

Biologics, cells and tissue warning letters: 29

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. The list gains about 1 row a month. The new rows come each week by email, $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. The weekly rows run until you cancel, from the link in each delivery.

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Updated October 13, 2026. Source: FDA warning letters (U.S. Food and Drug Administration).

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 request: Every new FDA warning letter on biologics, cells and tissue, with the company, the office and the letter. $10 of credit on sign-up, no card.

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.

• 29Letters
• 3With closeout
• October 13, 2026Latest issued

Newest letters

The newest 29 of 29 by issue date, each linked to the letter on fda.gov.

Subjects as FDA words them

By issuing office

By year issued

Where FDA publishes its warning letters

• FDA 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. Spot a wrong value? Write to [email protected] with the link to this page.