FDA Warning Letter Explorer

FDA warning letter · Drugs

Mineral BioSciences, LLC

Issued Jun 5, 2026 · Posted by FDA Jul 21, 2026

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 meet sanitation requirements that apply to your physical plant and grounds under 21 CFR 111.15. Specifically:

Citations in the original letter

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

21 CFR 111.15
21 CFR 111.15(b)
21 CFR 111.15(d)(2)
21 CFR 111.105(a)
21 CFR 111.255(b)
21 CFR 111.260
21 CFR 111.260(c)
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 111.75(a)(2)(ii)(A)
21 CFR 111.75(a)(2)
21 CFR 111.75(a)(1)(i)
21 CFR 111.75(a)(2)(ii)
21 CFR 111
21 CFR 201.5