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 establish the following specifications as required by 21 CFR 111.70:
Passage 2You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for conducting a material review and making a disposition decision, in accordance with 21 CFR 111.503.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 101.36
- 21 CFR 101.5
- 21 CFR 101.36(b)(2)(i)(B)
- 21 CFR 101.36(b)(2)(iii)(C)
- 21 CFR 101.36(b)(3)(iv)
- 21 CFR 101.36(b)(2)(iii)(D)
- 21 CFR 101.36(b)
- 21 CFR 101.7
- 21 CFR 101.4
- 21 CFR 101.4(g)
- 21 CFR 101.36(c)
- 21 CFR 101.36(c)(3)
- 21 CFR 101.3(g)
- 21 CFR 101.3(d)
- 21 CFR 101.36(b)(1)(ii)
- 21 CFR 101.4(h)(1)
- 21 CFR 101.93(b)
- 21 CFR 101.15(c)
- 21 CFR 101.13(j)
- 21 CFR 101.13(j)(2)(iv)(A)
- 21 CFR 101.9
- 21 CFR 101.9(b)
- 21 CFR 101.12(b)
- 21 CFR 101.2(e)
- 21 CFR 101.36(e)(6)
- 21 CFR 101.7(a)
- 21 CFR 111.503
- 21 CFR 111
- 21 CFR 111.70
- 21 CFR 111.70(f)
- 21 CFR 111.70(g)
- 21 CFR 111.103
- 21 CFR 111.55
- 21 CFR 111.105
- 21 CFR 111.127(h)
- 21 CFR 111.553
- 21 CFR 111.403
- 21 CFR 111.410
- 21 CFR 111.410(d)
- 21 CFR 111.453
- 21 CFR 111.455(a)
- 21 CFR 111.535(b)
- 21 CFR 111.16
- 21 CFR 111.23(b)
- 21 CFR 111.25(c)
- 21 CFR 111.35(b)(1)(iii)
- 21 CFR 201.5