Herbal Vitality, Inc.: FDA Warning Letter (Mar 7, 2023)

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 prepare a written master manufacturing record (MMR) that includes written instructions for corrective action plans for use when a specification is not met, as required by 21 CFR 111.210(h)(5). Specifically, your Pouring Formulas instruction sheet, which you provided in response to our request for your MMRs for the Children’s Tonsillitis/Otitis and Immune Tonic, does not include a corrective action plan for use when a specification is not met.

Passage 2
You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 101.36
21 CFR 101.36(e)(1)
21 CFR 101.4(h)
21 CFR 101.9(b)
21 CFR 101.12(b)
21 CFR 101.9(b)(7)
21 CFR 101.36(b)(1)(ii)
21 CFR 101.36(e)(6)(i)
21 CFR 101.36(c)(2)
21 CFR 101.36(b)(3)(ii)
21 CFR 101.36(c)(3)
21 CFR 101.4(g)
21 CFR 11.260(f)
21 CFR 111.75(h)(1)
21 CFR 111.210(h)(5)
21 CFR 111.70(b)(3)
21 CFR 111.95(b)(1)
21 CFR 111.70(e)
21 CFR 111.75(c)
21 CFR 111.95
21 CFR 111.123(a)(8)
21 CFR 111.123(a)(1)
21 CFR 111.255(b)
21 CFR 111.260
21 CFR 111.260(b)
21 CFR 111.260(c)
21 CFR 111.260(d)
21 CFR 111.260(g)
21 CFR 111.260(h)
21 CFR 111.260(i)
21 CFR 111.260(j)(ii)
21 CFR 111.260(j)(iv)
21 CFR 111.260(k)(1)
21 CFR 111.260(k)(2)
21 CFR 111.260(k)(3)
21 CFR 111.260(l)(1)
21 CFR 111.260(l)(2)
21 CFR 111.260(l)(4)
21 CFR 111.260(m)
21 CFR 111.260(n)
21 CFR 111.83(a)
21 CFR 111.83(b)(1)
21 CFR 111.3
21 CFR 111
21 CFR 201.5