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# CGMP, Data Issues Found in Chongqing Inspection
- URL: https://www.fdaweb.com/cgmp-data-issues-found-in-chongqing-inspection/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:09:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138079

A 5/16-5/19/16 FDA inspection at Chongqing Pharma Research Institute, Chongqing, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to a 2/14 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543347.htm?ref=fdaweb.com). Specific deviations included failing to maintain complete data derived from all laboratory tests conducted to assure compliance with established specifications and standards.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures and strongly recommends that it retain a qualified consultant to assist in remediation. Chongqing is to provide a comprehensive investigation into the extent of the inaccuracies in data records and reporting, a current risk assessment of the potential effects of the observed failures on the quality of its drugs, and a management strategy for the company that includes the details of its global corrective action and preventive action plan.

The company 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.