Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].
Passage 2You failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR 312.62(a)].
Passage 3You failed to adhere to these requirements. Specifically, for six subjects enrolled on Protocol **(b)(4)**, the following discrepancies were observed between the quantity of drug used by the subjects and the quantity of drug returned, as recorded on the site IP accountability record; the EDC records of subjects’ self-reported doses; and the EDC records of site-reported IP returned (used and unused):
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 312.60
- 21 CFR 312.62(a)
- 21 CFR 312