> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Wuhan Chinese Moxibustion CGMP Violations Cited
- URL: https://www.fdaweb.com/wuhan-chinese-moxibustion-cgmp-violations-cited/
- Published: 2018-01-16T12:00:00.000Z
- Updated: 2026-09-14T23:13:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140509

A 5/22-5/26/17 FDA inspection at Wuhan Chinese Moxibustion Technology Dev. Co., Ltd., Wuhan, Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591840.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, labeling, and drug products, and the authority to review all production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated;
- failing to prepare master production and control records designed to assure uniformity from batch to batch;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish written procedures for production and process control designed to assure that the products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of a drug product beyond the official or other established requirements.

The agency recommended that the firm retain a qualified consultant to assist it in meeting CGMP requirements. The letter also noted labeling issues with the company’s patch drug products being evaluated for over-the-counter drug review. The firm was placed on an import alert 10/19/17.

Wuhan was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.