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 prepare a final report for each nonclinical laboratory study that includes, but is not limited to, the following: (1) name and address of the testing facility; (2) name of the study director and other scientists or professionals involved in the study; (3) locations where all specimens, raw data, and final reports are to be stored; and (4) study director’s signature and date [21 CFR 58.185(a)(1), 58.185(a)(10), 58.185(a)(13), and 58.185(b)].
Passage 2You failed to adhere to these requirements. Specifically, the final reports for studies **(b)(4)** that Vedic submitted to the sponsor did not contain complete and accurate information for the above-described items that were required to be included in the final report. Examples include but are not limited to the following:
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 58
- 21 CFR 58.185(a)(1)
- 21 CFR 58.33