FDA WARNING_LETTER - RPG Life Sciences Limited - January 31, 2013

The FDA issued a Warning Letter to RPG Life Sciences Limited following inspections of their Ankleshwar (November 20-24, 2012) and Navi Mumbai (January 28-31, 2013) facilities, identifying significant CGMP violations for finished pharmaceuticals and APIs, respectively. These violations render their products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

At MS-Ankleshwar, violations included failure to investigate OOS results (21 CFR 211.192), such as stability assay failures and impurity exceedances, with the firm selectively reporting passing retest values and lacking documentation for retrospective investigations. The firm also failed to follow laboratory control mechanisms (21 CFR 211.160(a)), discarding raw data and using multiple HPLC processing methods without justification. Additionally, laboratory records lacked complete data (21 CFR 211.194(a)), with raw data for sample preparations missing and "trial" injections not documented. Controls over computer systems were inadequate (21 CFR 211.68(b)), allowing analysts to delete and overwrite electronic data and backdate records.

At MS-Navi Mumbai, the firm failed to investigate and document OOS results (e.g., stability assays exceeding impurity limits), discarding raw data and lacking scientific evidence for root causes. Complaint