On 24 February, FDA warned Jinan Jinda following a three-day inspection of the company’s Zhangqiu City, China facility where it manufactures active pharmaceutical ingredients last spring.
The facility was also placed on import alert in November 2015 following an audit earlier that month. Neither FDA nor Jinan Jinda have said why the facility was placed on import alert, though the Italian Medicines Agency cited the company a few months earlier for over a “serious risk of data falsification.”
Few points noted by USFDA are:
- Company’s quality control lab disregarded multiple out-of-specification (OOS) impurity test results without justification.
- For example, on September 22, 2015, you encountered an OOS unknown impurity peak during high performance liquid chromatography (HPLC) testing of [Redacted] 36-month stability batch [Redacted]. Company terminated the analysis. Testing of a new sample also showed the OOS impurity peak. The chromatogram was then manually rescaled, which hid the presence of this peak.
- FDA says the company ran the same 60-month stability test seven times, deleting the first five results and renaming the final two. The company then reported that the tests met specifications.
- FDA also cites the company for failing to restrict access to its laboratory systems, including its high performance liquid chromatography, gas chromatography and ultra-violet systems.