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Reine Lifescience gets US FDA warning letter for contravention of cGMP norms for APIs

Warning letter has been issued to Reine Life science by US Food and Drug Administration (FDA) on May 9, 2018. Reine Lifescience is a manufacturer of Active Pharmaceutical Ingredients (APIs) located in Gujarat. The warning letter summarizes significant deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API).The company failed to authenticate and substantiate the appropriateness of analytical methods, as reported by the FDA officials who inspected Reine's manufacturing facility in GIDC Industrial Estate from October 30 to November 3 last year. The other findings are wrong documentation and no satisfactory control over computerized system to prevent illegal access.

The other findings are wrong documentation; the investigator found that the analytical data is stored in the folder named “PD trial”. “PD trial” folder is generally intended for product development. No satisfactory control over computerized system to prevent illegal access and also analytical system lacked controls to prevent unauthorized access to electronic data. It is also found by the investigator that the quality system does not ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured by the firm.

As a result, FDA placed an import alert 66-40 on the firm and also denies approval of any new drug applications or supplements manufactured by the firm until all the deviations are corrected.