FDA Warning LettersorganizationID: fda-warning-letter-21379c1f5f6b16eb

Smart Surgical, Inc dba Burst Biologics

Primary Source
FDA WARNING LETTER
Coverage
Global
Risk Tier
High
Last Updated
2026-07-26

Compliance Profile

"Risk Advisory: Records indicate that Smart Surgical, Inc dba Burst Biologics is associated with FDA WARNING LETTER. Source-list verification is recommended."

Banking Impact

Records on FDA WARNING LETTER can trigger enhanced due diligence, compliance holds, counterparty review and documentation requests from banks, investors or procurement teams.

Legal Status

The record should be reviewed against the original source list, jurisdiction and date of publication before decisions are made. Escalation may be required for procurement, onboarding or investor diligence.

Official Source Metadata

Source: FDA Warning Letters
Full Legal NameSmart Surgical, Inc dba Burst Biologics
Source Records
FDA WARNING LETTER
Enforcement TypeFDA Warning Letters
Identifiers2022-02-02 / Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Risk Topicsreg.action, reg.warn, sector.medical
Official SourceView source record

Associated Subject Network

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Independent Risk Assessment

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