What happened
Original notice title
Herbal Doctor Remedies MARCS-CMS 583205, October 04, 2019
From the archived source record
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, your drug products are adulterated within the meaning of section 501(a)(2)(A) of the Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A). Additionally, because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B). FDA also reviewed your websites at www.herb-doc.com, www.theraherb.ecrater.com, and www.chinasecretremedy.com, in July 2019, and has determined that you take orders there for various products that are unapproved new drugs and misbranded drugs under sections 502(f)(1) and 505(a) of the FD&C Act, 21 U.S.C. 352(f)(1), and 355(a). Under section 502(o) of the FD&C Act (21 U.S.C. 352(o)), the failure to register an establishment as required by section 510, or failure to list a drug as required under section 510(j), renders a drug misbranded. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP. During our inspection, our investigators observed specific violations including, but not limited to, the following. Insanitary Conditions Violations You manufactured finished drug products intended to orally and topically treat conditions, such as autism, Alzheimer’s disease, herpes, and cancer. Your firm failed to establish an adequate quality unit with adequate facilities and procedures to ensure that drugs are manufactured in compliance with CGMP regulations and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 8e50aa235fab
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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