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US FDA source recordWL · Warning Letter

Center For Immunology Science, LLC — FDA Warning Letter

Issued to Center For Immunology Science, LLC. Serious post-market compliance violation.

Issued

January 13, 2026

Product

Sponsor/Investigator

Company

Center For Immunology Science, LLC

Review center

CDER

Stage

Final Decision

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Why did Center For Immunology Science, LLC receive an FDA warning letter?

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Source facts

FDA issued a warning letter to Center For Immunology Science, LLC concerning Sponsor/Investigator. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

Key details in this letter

  • 1Subject: Sponsor/Investigator.
  • 2Issuing office: Center for Drug Evaluation and Research (CDER).
  • 3No closeout letter was listed in the source metadata at refresh time.

Suggested next step

Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAHTMLUpdated Jul 30, 2026

FDA source document

Read the full FDA warning letter

FDA publishes this warning letter as a web document.

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Common questions about the Center For Immunology Science, LLC warning letter

What does this warning letter mean for Center For Immunology Science, LLC?

Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on January 13, 2026.

What happens after an FDA warning letter?

The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.