STPCA Inc. dba Sun Ten Laboratories
2 extracted findings
FDA source excerpt, selected passage
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:
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
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:
Source passage selected by the model
02
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:
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.
21 CFR 111.7021 CFR 111.75(c)21 CFR 111.75(a)(2)21 CFR 201.521 CFR 111.70(a)21 CFR 111.70(b)(1)21 CFR 111.70(b)(2)21 CFR 111.70(e)21 CFR 111.7321 CFR 111.75(a)(1)(i)21 CFR 111.75(a)(1)(ii)21 CFR 111.70(b)21 CFR 111.9521 CFR 111.113(a)(1)21 CFR 111.21021 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 101.15(c)21 CFR 101.4(h)(1)21 CFR 101.4(h)21 CFR 101.3621 CFR 101.36(e)(1)21 CFR 101.36(b)(2)(iii)(E)21 CFR 111