STPCA Inc. dba Sun Ten Laboratories: FDA Warning Letter (Apr 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
Your firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.70(a). Specifically:

Passage 2
You failed to establish master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, the MMRs for your Lycium Formula Huan Shao Dan, **(b)(4)**, and **(b)(4)** Zinc **(b)(4)** products failed to include:

Citations in the original letter

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

21 CFR 101.15(c)
21 CFR 101.4(h)(1)
21 CFR 101.4(h)
21 CFR 101.36
21 CFR 101.36(e)(1)
21 CFR 101.36(b)(2)(iii)(E)
21 CFR 111.70
21 CFR 111.75(c)
21 CFR 111.75(a)(2)
21 CFR 111.70(a)
21 CFR 111.70(b)(1)
21 CFR 111.70(b)(2)
21 CFR 111.70(e)
21 CFR 111.73
21 CFR 111.75(a)(1)(i)
21 CFR 111.75(a)(1)(ii)
21 CFR 111.70(b)
21 CFR 111.95
21 CFR 111.113(a)(1)
21 CFR 111.210
21 CFR 111.210(g)
21 CFR 111.210(b)
21 CFR 111.210(c)
21 CFR 111.210(d)
21 CFR 111.210(e)
21 CFR 111.210(f)
21 CFR 111.210(h)
21 CFR 111.210(h)(1)
21 CFR 111.210(h)(2)
21 CFR 111.210(h)(3)
21 CFR 111.210(h)(3)(i)
21 CFR 111.210(h)(3)(ii)
21 CFR 111.210(h)(3)(ii)(A)
21 CFR 111.210(h)(3)(ii)(B)
21 CFR 111
21 CFR 201.5