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# API Deviations Found at China’s Jilin Shulan
- URL: https://www.fdaweb.com/api-deviations-found-at-chinas-jilin-shulan/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141543

An 11/7-11/10/17 FDA inspection at Jilin Shulan Synthetic Pharmaceutical Co., Shulan City, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to a 5/14 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm608713.htm?ref=fdaweb.com). Specific deviations cited in the letter were: 

- failing to document known deviations and out-of-specification results and to conduct a thorough investigation;
- failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failing to have adequate controls to prevent omission of data; and
- failing to record activities at the time they are performed.

“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” FDA says. “Your firm must provide the quality unit with the appropriate authority, sufficient resources, and qualified staff to carry out its responsibilities and consistently ensure drug quality.” The agency recommended that the firm retain a qualified consultant to assist in remediation.

Jilin was told to provide **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on drug quality; and **(3)** a management strategy for the firm that includes details of a global corrective and preventive action plan. The firm was placed on an import alert 3/1.

The company was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.