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FDA Warning Letter Explorer
FDA warning letter · Drugs

American Chinese Natural Herbs, Inc.

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 the required specifications for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you did not establish specifications for the components used for your dietary supplement products. For example, you have not established component specifications for the identity of the following dietary ingredients:

Passage 2

You failed to establish MMRs for your products that include all elements required by 21 CFR 111.210. Specifically, the MMR for your products Stomach Miracle, Thorough Wax Extract, and Almond Plus, failed to include the information required by 21 CFR 111.210, such as:

Passage 3

You failed to prepare a batch production record every time you manufactured a batch of dietary supplement as required by 21 CFR 111.255(a). Specifically, during the inspection, your firm did not have batch production records (BPRs) for all products that had been manufactured, such as Almond Plus and Stomach Miracle.

Passage 4

Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision as required by 21 CFR 111.103. Specifically, your firm did not establish written procedures that included procedures to follow for conducting a material review and make a disposition decision for each lot of finished dietary

Citations in the original letter

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

  • 21 CFR 101.4(h)(2)
  • 21 CFR 101.36
  • 21 CFR 101.36(a)
  • 21 CFR 101.3(g)
  • 21 CFR 101.4
  • 21 CFR 101.36(d)(1)
  • 21 CFR 101.4(h)(1)
  • 21 CFR 101.15(c)
  • 21 CFR 101.9(b)
  • 21 CFR 101.12(b)
  • 21 CFR 101.93(b)
  • 21 CFR 101.4(g)
  • 21 CFR 101.36(c)(2)
  • 21 CFR 101.2(e)
  • 21 CFR 111.260
  • 21 CFR 111.210
  • 21 CFR 111.70(b)
  • 21 CFR 111.70(e)
  • 21 CFR 111.210(a)
  • 21 CFR 111.210(b)
  • 21 CFR 111.210(c)
  • 21 CFR 111.210(d)
  • 21 CFR 111.210(e)
  • 21 CFR 111.210(g)
  • 21 CFR 111.210(h)
  • 21 CFR 111.210(h)(1)
  • 21 CFR 111.210(h)(2)
  • 21 CFR 111.210(h)(3)
  • 21 CFR 111.210(h)(3)(i)
  • 21 CFR 111.210(h)(3)(ii)
  • 21 CFR 111.210(h)(3)(ii)(A)
  • 21 CFR 111.210(h)(3)(ii)(B)
  • 21 CFR 111.210(h)(4)
  • 21 CFR 111.210(h)(5)
  • 21 CFR 111.255(a)
  • 21 CFR 111.260(d)
  • 21 CFR 111.260(f)
  • 21 CFR 111.260(g)
  • 21 CFR 111.260(h)
  • 21 CFR 111.260(i)
  • 21 CFR 111.260(k)
  • 21 CFR 111.260(l)
  • 21 CFR 111.260(n)
  • 21 CFR 111.553
  • 21 CFR 111.560(a)
  • 21 CFR 111.103
  • 21 CFR 111