What happened
Original notice title
KDunn and Associates, P.A. dba HealthQuilt MARCS-CMS 611864, February 16, 2021
From the archived source record
The investigational drug (b)(4) used in the study was an unapproved new drug, administered to human subjects (b)(4) for (b)(4) to treat, cure, and prevent COVID-19. (b)(4) is not a lawfully marketed drug product in the United States and therefore was not exempt from the IND requirements. Subjects were administered (b)(4) , an unapproved drug, (b)(4) for (b)(4) for the treatment, cure, and prevention of COVID-19. Without these details, we are unable to determine whether HealthQuilt’s corrective action plan is adequate to prevent similar violations in the future. 2. HealthQuilt noted that it did not perceive any significant risk to the security of the product during transport, since it was delivered to HealthQuilt from the manufacturer in a private vehicle. HealthQuilt’s written response is inadequate because it did not provide sufficient details about its plan for implementing additional measures and procedures to address the inspection findings concerning its failure to maintain adequate records. As a result, we are unable to determine whether HealthQuilt’s plans appear sufficient to prevent similar violations in the future. 3. We are unable to determine if this written response provides a corrective action plan that, if properly carried out, would prevent this type of violation in the future. Without these details, we are unable to determine whether your corrective action plan for removing exculpatory language from informed consent forms for studies subject to the requirements of 21 CFR part 50 is adequate to prevent similar violations in the future. 4. As a result, we are unable to determine whether your plan appears sufficient to prevent similar violations in the future. Within fifteen (15) working days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- d24c8a4f7fa3
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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