Spartan Enterprises Inc. dba Watershed Wellness Center
2 extracted findings
FDA source excerpt, selected passage
You failed to establish specifications required under 21 CFR 111.70. 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
You failed to establish specifications required under 21 CFR 111.70. Specifically:
Source passage selected by the model
02
You failed to maintain your physical plant in a clean and sanitary condition, as required by 21 CFR 111.15(b)(1). Specifically:
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 101.36(b)(3)21 CFR 101.9(c)21 CFR 111.21021 CFR 111.26021 CFR 101.36(b)(2)21 CFR 111.7021 CFR 111.70(e)21 CFR 111.260(j)21 CFR 111.260(k)21 CFR 101.3621 CFR 101.9(b)21 CFR 101.721 CFR 201.521 CFR 111.70(b)(2)21 CFR 111.7521 CFR 111.75(h)(1)21 CFR 111.95(b)(1)21 CFR 111.205(a)21 CFR 111.210(d)21 CFR 111.210(f)21 CFR 111.210(g)21 CFR 111.210(h)(1)21 CFR 111.210(h)(2)21 CFR 111.210(h)(3)21 CFR 111.210(h)(5)21 CFR 111.210(a)21 CFR 111.210(c)21 CFR 111.210(b)21 CFR 111.255(a)21 CFR 111.260(b)21 CFR 111.260(c)21 CFR 111.260(d)21 CFR 111.260(e)21 CFR 111.260(f)21 CFR 111.260(g)21 CFR 111.260(h)21 CFR 111.260(i)21 CFR 111.260(l)(3)21 CFR 111.260(m)21 CFR 111.15(b)(1)21 CFR 111.105(a)21 CFR 111.123(a)(1)21 CFR 101.521 CFR 101.3(g)21 CFR 101.421 CFR 101.4(h)(1)21 CFR 101.12(b)21 CFR 101.36(e)(1)21 CFR 101.36(b)(2)(iii)(D)21 CFR 101.7(b)(1)21 CFR 101.93(b)21 CFR 111.70(b)21 CFR 111.75(a)(2)(ii)21 CFR 101.15(c)21 CFR 111