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FDA Warns Two Drugmakers in China and India for Data Integrity Violations

Posted 21 March 2017 | By Michael Mezher 

FDA Warns Two Drugmakers in China and India for Data Integrity Violations

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Data integrity has been a growing area of focus for FDA, with an increasing number of warning letters and Form 483s citing data integrity violations, many for manufacturers in China and India.

USV Warning Letter

In a warning letter dated 10 March 2017, FDA cites USV for issues related to sterility testing for its products and data integrity violations at the company's Daman site where it manufactures solid-oral formulations, injectables and ophthalmic drugs.

FDA also warned USV for data integrity violations at USV's Mumbai, India facility in 2014, citing the company for backdating records and for failing to restrict access to its quality control systems.

At the time, FDA acknowledged that USV had hired a consultant to review its data integrity practices and provided the company with a seven point list of data integrity issues that the consultant should address.

However, with the release of the new warning letter it appears that the company did not address FDA's data integrity concerns at all its facilities.

"These repeated problems at multiple sites demonstrate that your company's oversight and control over the manufacture of drugs is inadequate," FDA writes.

In this instance, FDA says USV found a total of 25 instances of deleted test results in the audit trails for two instruments used to test for sterility after FDA investigators identified six initial deleted records.

"Your systems allowed operators to delete files. You had no procedure to control this practice or to ensure a backup file was maintained," FDA writes.

Additionally, FDA said the company didn't restrict access to the external hard drives used to back up its microbial identification equipment, noting that any user could delete or modify files on the drive.

On top of the data integrity issues, FDA said it also found issues with the company's sterility testing operations, including issues with the media plates used for microbiological testing and failure to identify bacterial and fungal specimens found during environmental monitoring.

Jinan Jinda Warning Letter

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."

In the warning letter, FDA says the 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]. You 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."

In another instance, 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.

USV Warning Letter

Jinan Jinda Warning Letter

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