KDunn and Associates, P.A. dba HealthQuilt — FDA Warning Letter Findings

You failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug (21 CFR 312.57(a)). As a sponsor, HealthQuilt was required to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug (b)(4) . These records were required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each shipment…

You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20]. As a clinical investigator, it is your responsibility to obtain informed consent in accordance with 21 CFR part 50. FDA's regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally…

You failed to submit an IND for the conduct of clinical investigations with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)]. In relevant part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man…

You failed to retain records required to be maintained under 21 CFR part 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the investigation is discontinued [21 CFR 312.62(c)]. As a clinical investigator, you are required to prepare and maintain adequate and…