KDunn and Associates, P.A. dba HealthQuilt

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)].

Passage 2

You failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug (21 CFR 312.57(a)).

Passage 3

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].

Passage 4

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)].

Passage 5

You failed to adhere to these requirements. You were required to retain case histories, including informed consent forms, for a period of two years following discontinuation of the investigation, which was on July 23, 2020; however, you failed to retain at least eight signed and dated informed consent forms.