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# API Deviations Found in Changzhou Jintan Inspection
- URL: https://www.fdaweb.com/api-deviations-found-in-changzhou-jintan-inspection/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138758

A 2/13-2/17 FDA inspection at Changzho Jintan Qianyao Pharmaceutical Raw Materials Factory, Changzhou City, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 5/11 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558917.htm?ref=fdaweb.com). Specific deviations noted in the letter were: 

- failing to implement a system for managing quality encompassing the organizational structure, procedures, processes, and resources, as well as activities to ensure confidence that API will meet its intended specifications for quality and purity, and failing to define and document all quality-related activities;
- failing to have adequate written procedures for the receipt, identification, quarantine, storage, sampling, testing, handling, and approval or rejection of raw materials;
- failing to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards; and
- failing to prepare adequate batch production records and record the activities at the time they are performed.

 “Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations, and to assist your firm in meeting CGMP requirements,” the letter says. FDA placed the company on an import alert 5/4.

Changzhou Jintan was told to respond with a list of steps it has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.