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# CGMP Violations at Guangzhou Tinci
- URL: https://www.fdaweb.com/cgmp-violations-at-guangzhou-tinci/
- Published: 2020-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:06:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146288

A 7/29-8/2/19 FDA inspection at Guangzhou Tinci Materials Technology Co., Guangzhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-tinci-materials-technology-co-ltd-592199-01232020?ref=fdaweb.com) says the specific violations were: 

- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance;
- failing to conduct, for each batch of a drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms; and
- failing to establish an adequate quality control unit and to fully follow a written description of the responsibilities and procedures applicable to the quality control unit.

FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. It also recommends that the consultant perform a comprehensive audit of the company’s entire operation for CGMP compliance and evaluate the completion and efficacy of the firm’s corrective and preventive actions before Guangzhou pursues resolution of its compliance status with the agency.

FDA placed the company on an import alert on 11/27/19.

Guangzhou was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence with a schedule for completion of the corrective actions.