Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.: FDA Warning Letter (Aug 1, 2023)

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 the specifications required under 21 CFR 111.70. Specifically:

Passage 2
You failed to establish and follow written procedures for the requirements to review and investigate a product complaint, as required under 21 CFR 111.553. Specifically, our investigators requested your written procedures to review and investigate a product complaint. You stated that you did not have this procedure, and you did not provide it.

Passage 3
You failed to establish and follow written procedures for when a returned dietary supplement is received, as required under 21 CFR 111.503. Specifically, our investigators requested your written procedures for when a returned dietary supplement is received. You stated that you did not have these written procedures, and none were provided.

Passage 4
You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection, you said you had not established written procedures for holding and distributing operations.

Citations in the original letter

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

21 CFR 101.36
21 CFR 101.9(b)
21 CFR 101.12(b)
21 CFR 101.36(e)(1)
21 CFR 101.36(c)(2)
21 CFR 101.36(b)(3)(ii)(A)
21 CFR 101.4(h)(1)
21 CFR 101.4(h)
21 CFR 101.4
21 CFR 101.93(d)
21 CFR 101
21 CFR 111.70
21 CFR 111.70(b)
21 CFR 111.75(c)
21 CFR 111
21 CFR 111.70(b)(1)
21 CFR 111.70(b)(2)
21 CFR 111.70(d)
21 CFR 111.70(e)
21 CFR 111.73
21 CFR 111.75(a)(1)(i)
21 CFR 111.75(a)(1)(ii)
21 CFR 111.75(a)(2)
21 CFR 111.95
21 CFR 111.103
21 CFR 111.140(b)(1)
21 CFR 111.205(a)
21 CFR 111.255(b)
21 CFR 111.260
21 CFR 111.260(b)
21 CFR 111.260(c)
21 CFR 111.260(d)
21 CFR 111.260(f)
21 CFR 111.260(g)
21 CFR 111.260(h)
21 CFR 111.260(j)
21 CFR 111.260(j)(1)
21 CFR 111.260(j)(2)
21 CFR 111.260(k)
21 CFR 111.260(k)(1)
21 CFR 111.260(k)(2)
21 CFR 111.260(k)(3)
21 CFR 111.260(l)
21 CFR 111.260(l)(1)
21 CFR 111.260(l)(i)
21 CFR 111.260(l)(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 111.553
21 CFR 111.503
21 CFR 111.453
21 CFR 111.475(b)(1)
21 CFR 111.27(d)
21 CFR 111.25(c)
21 CFR 201.5