> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Deviations at India’s Reine Lifescience
- URL: https://www.fdaweb.com/cgmp-deviations-at-indias-reine-lifescience/
- Published: 2018-05-15T12:00:00.000Z
- Updated: 2026-09-15T00:05:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141436

A 10/30-11/3/17 FDA inspection at Reine Lifescience, Gujurat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 5/9 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607583.htm?ref=fdaweb.com) saysthat specific deviations were: 

- failing to validate and verify the auditability of analytical methods;
- 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 adequately validate written procedures for cleaning and maintaining equipment.

Because of the nature of the deviations identified at the firm, FDA strongly recommends it engage a consultant qualified to evaluate its operations and assist it in meeting CGMO requirements. The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures and says the company should provide **(1)** a comprehensive investigation into the extend of data record and reporting inaccuracies; **(2)** a current risk assessment of the potential effects of the observed poor practices on the quality of the firm’s drugs; and **(3)** a management strategy for the firm that includes the details of its global corrective action and preventive action plan.

Reine Lifescience was placed on an import alert 3/30\. It was told to respond to the Warning Letter with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.