What happened
Original notice title
American Chinese Natural Herbs, Inc. MARCS-CMS 631597, February 10, 2023
From the archived source record
Based on inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We have reviewed that document and our comments on your response are listed following each of the significant violations. Adulterated Dietary Supplements The inspection of your facility revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of CGMP requirements are as follows: 1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you provided the investigator with a “Return Policy for product Complaints.” The policy states that you refund or exchange the product, that you refer to the “Batch Production Record” and that your quality control personnel reexamine the batch “to ensure [whether] the batch was contaminated.” It also states that if multiple reports and complaints are received “in a (b)(4) time span,” that the batch will be sent to a laboratory for testing. Your product complaint procedures failed to include that a qualified person will review all product complaints (not only on the basis of returned products) and will investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, not only when you have multip
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 5c2e6edfdc05
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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