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# Latest FDA Warning Letter
- URL: https://www.fdaweb.com/latest-fda-warning-letter-13/
- Published: 2021-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:48:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148782

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

**HealthQuilt**, Houston, TX (2/16) FDA inspected the firm 8/4-8/13/2020 under its bioresearch monitoring program inspection and cited objectionable conditions in the company’s work as the sponsor of a clinical investigation into a Covid-19 investigational drug. For example, the firm failed to submit an IND for the conduct of clinical investigations and it also failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. Additionally, it failed to obtain informed consent following regulatory provisions. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kdunn-and-associates-pa-dba-healthquilt-611864-02162021?ref=fdaweb.com).