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# Chinese Drug Firm Added to Import Alert Listing
- URL: https://www.fdaweb.com/chinese-drug-firm-added-to-import-alert-listing/
- Published: 2016-01-21T12:00:00.000Z
- Updated: 2026-09-15T02:29:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134511

FDA has issued an [import ban](http://www.accessdata.fda.gov/cms%5Fia/importalert%5F189.html?ref=fdaweb.com) against China’s Zhejiang Hisoar Pharmaceutical Co. for all drug products produced at its Taizhou City manufacturing plant due to GMP deviations. An agency inspection in August found that quality records had been deleted and test records were altered, according to a Bloomberg report.

Manufacturing plants in China and India have been in FDA’s sights for the past few years. Hisoar Pharmaceutical Co. is now the 41st company in China to be placed on import alert, according to agency records.

Earlier this month, FDA posted a [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480035.htm?ref=fdaweb.com) sent to Zhejiang Hisun Pharmaceutical Co., Zhejiang Province, China, that also found significant GMP deviations. The firm was placed on import alert 9/2015\. Specific deviations cited in the letter included:

- failing to prevent unauthorized access and changes to data, and to provide adequate controls to prevent manipulation and omission of data; and
- failing to conduct appropriate microbiological testing on API batches where microbial quality is specified.

The letter said that agency investigators discovered a lack of basic laboratory controls to prevent changes to the firm’s electronically stored data and paper records. It was found that the company relied on incomplete records to evaluate the quality of its drugs and to determine whether they conformed with established specifications and standards. Investigators also determined, the letter said, that the firm routinely re-tested samples without justification and deleted analytical data.