Smart Surgical, Inc dba Burst Biologics

Warning LetterOpen

Mr. Christopher D. Jones Chief Executive Officer Smart Surgical, Inc dba Burst Biologics 3501 W. Elder St., Ste. 104 Boise , ID 83705 United StatesFEI 3009744960Issued Feb 2, 2022Office of Biological Products Operations – Division 2

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009744960.

Violations11

Issue DateFeb 2, 2022

Product TypeBiologics

StatusOpen

Letter Details

Firm: Smart Surgical, Inc dba Burst Biologics
Location: Mr. Christopher D. Jones Chief Executive Officer Smart Surgical, Inc dba Burst Biologics 3501 W. Elder St., Ste. 104 Boise , ID 83705 United States
FEI Number: 3009744960
Country: United States
Issue Date: February 02, 2022
Issuing Office: Office of Biological Products Operations – Division 2
Product Type: Biologics
Status: Open

Summary

Smart Surgical, Inc dba Burst Biologics manufactured and distributed human umbilical cord blood-derived products (BioBurst Fluid and BioBurst Rejuv) intended for injection to treat various diseases, which the FDA determined were biologics and drugs requiring premarket review rather than products that could be regulated solely under section 361 of the Public Health Service Act. The company's human cell, tissue, and cellular products (HCT/Ps) failed to meet the criteria in 21 CFR 1271.10(a) and did not qualify for any applicable exemption under 21 CFR 1271.15, placing them outside the scope of products exempt from full drug and biological product regulation. The FDA's inspection between February and March 2021 documented these regulatory violations and the company's failure to comply with applicable HCT/P regulations under 21 CFR Part 1271.

Smart Surgical, Inc dba Burst Biologics FDA Warning Letter, February 2, 2022