MYA International, Inc.: FDA Warning Letter (Feb 24, 2022)

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 establish component specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish component specifications that are necessary to ensure that specifications for the identity, purity, strength, composition and limits on contamination of the dietary supplements manufactured using the components are met. For example, you have not established such component specifications for:

Citations in the original letter

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

21 CFR 101.36
21 CFR 101.9(c)
21 CFR 101.36(d)
21 CFR 101.36(b)(2)(i)
21 CFR 101.36(b)(2)(iii)
21 CFR 101.9(b)
21 CFR 101
21 CFR 101.15(c)
21 CFR 101.36(b)(2)(ii)(B)
21 CFR 101.36(b)(3)(ii)(A)
21 CFR 101.9(d)(7)(i)
21 CFR 101.36(c)(2)
21 CFR 101.36(e)(6)
21 CFR 101.36(b)(2)(i)(B)(2)
21 CFR 101.9
21 CFR 101.36(b)(3)(iv)
21 CFR 101.36(e)(1)
21 CFR 101.36(e)
21 CFR 101.36(b)(2)(i)(A)
21 CFR 101.4
21 CFR 101.7
21 CFR 101.4(h)(1)
21 CFR 101.36(b)(1)(i)
21 CFR 101.12(b)
21 CFR 101.5(d)
21 CFR 101.2(e)
21 CFR 101.4(g)
21 CFR 101.3(d)
21 CFR 111.70(b)
21 CFR 111.75(a)(2)
21 CFR 111.70(e)
21 CFR 111.75(c)
21 CFR 111.75(a)(1)(i)
21 CFR 111.75(a)(1)(ii)
21 CFR 111.75(h)(1)
21 CFR 111.95(b)(1)
21 CFR 111.255(a)
21 CFR 111.255(b)
21 CFR 111.260
21 CFR 111.365(k)
21 CFR 111
21 CFR 201.5