BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Spartan Enterprises Inc. dba Watershed Wellness Center

Issued · Posted by FDA

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 specifications required under 21 CFR 111.70. Specifically:

Passage 2

You failed to maintain your physical plant in a clean and sanitary condition, as required by 21 CFR 111.15(b)(1). Specifically:

Citations in the original letter

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 101.36(b)(2)
  • 21 CFR 101.36
  • 21 CFR 101.9(b)
  • 21 CFR 101.7
  • 21 CFR 101.5
  • 21 CFR 101.3(g)
  • 21 CFR 101.4
  • 21 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 101.15(c)
  • 21 CFR 111.210
  • 21 CFR 111.260
  • 21 CFR 111.70
  • 21 CFR 111.70(e)
  • 21 CFR 111.260(j)
  • 21 CFR 111.260(k)
  • 21 CFR 111.70(b)(2)
  • 21 CFR 111.75
  • 21 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 111.70(b)
  • 21 CFR 111.75(a)(2)(ii)
  • 21 CFR 111
  • 21 CFR 201.5