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FDA Warning Letter Explorer
FDA warning letter · Drugs

C R Supplements, LLC

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 prepare a BPR every time you manufactured a batch of dietary supplements and to prepare a BPR that includes all required information, as required by 21 CFR 111.255(a) and 21 CFR 111.260. Specifically, you provided our investigator BPRs that were used for multiple production runs of dietary supplements, rather than for individual batches.

Passage 2

Your Silver and Magnesium products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Supplement Facts label) is not in a correct format, as required by 21 CFR 101.9. Foods, other than infant formula, represented or purported to be specifically for children one (1) through three (3) years of age shall bear nutrition labeling for those age groups, as required by 21 CFR 101.9(j)(5). Your Silver and Magnesium products do not provide nutrition information for children between one (1) year and three (3) years of age. There are specific requirements for children under four (4) years of age and under two (2) years of age, per 21 CFR 101.9(j)(5).

Citations in the original letter

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

  • 21 CFR 101.9
  • 21 CFR 101.9(j)(5)
  • 21 CFR 101.36(b)(2)(iii)(E)
  • 21 CFR 101.36
  • 21 CFR 101.9(c)
  • 21 CFR 101.36(b)(2)(i)
  • 21 CFR 101.4(g)
  • 21 CFR 111.70(e)
  • 21 CFR 111.210
  • 21 CFR 111.210(h)
  • 21 CFR 111.260
  • 21 CFR 111
  • 21 CFR 111.70(a)
  • 21 CFR 111.70
  • 21 CFR 111.70(b)
  • 21 CFR 111.70(c)(1)
  • 21 CFR 111.70(d)
  • 21 CFR 111.70(g)
  • 21 CFR 111.73
  • 21 CFR 111.75
  • 21 CFR 111.95
  • 21 CFR 111.103
  • 21 CFR 111.140(b)(2)
  • 21 CFR 111.65
  • 21 CFR 111.55
  • 21 CFR 111.105
  • 21 CFR 111.127(h)
  • 21 CFR 111.205(a)
  • 21 CFR 111.205
  • 21 CFR 111.205(b)(1)
  • 21 CFR 111.210(d)
  • 21 CFR 111.210(e)
  • 21 CFR 111.210(g)
  • 21 CFR 111.210(h)(2)
  • 21 CFR 111.210(h)(3)
  • 21 CFR 111.210(h)(4)
  • 21 CFR 111.255(a)
  • 21 CFR 111.260(c)
  • 21 CFR 111.260(d)
  • 21 CFR 111.260(h)
  • 21 CFR 111.260(i)
  • 21 CFR 111.260(j)(1)
  • 21 CFR 111.260(j)(2)(i)
  • 21 CFR 111.260(j)(2)(ii)
  • 21 CFR 111.260(j)(2)(iii)
  • 21 CFR 111.260(j)(2)(iv)
  • 21 CFR 111.260(k)(1)
  • 21 CFR 111.260(k)(2)
  • 21 CFR 111.260(k)(3)
  • 21 CFR 111.260(l)(1)(i)
  • 21 CFR 111.260(l)(1)(ii)
  • 21 CFR 111.260(l)(2)
  • 21 CFR 111.260(l)(3)
  • 21 CFR 111.260(l)(4)
  • 21 CFR 111.260(m)
  • 21 CFR 111.260(n)
  • 21 CFR 111.260(j)
  • 21 CFR 111.260(k)
  • 21 CFR 111.260(l)
  • 21 CFR 201.5