USFDA finds CGMP violations at Reliance plant
The United States Food and Drug Administration (USFDA) has issued a warning letter to Reliance Life Sciences Pvt Ltd over “significant violations” of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at its Navi Mumbai manufacturing facility. The USFDA inspected Dhirubhai Ambani Life Sciences Centre located at R-282, TTC Area of MIDC in Navi Mumbai, from February 19-27, 2026, the health regulator said.
In its warning letter, the USFDA said the firm failed to ensure laboratory records included complete data from all tests necessary to ensure compliance with established specifications and standards. It further said that Reliance Life Sciences failed to establish and follow appropriate written procedures designed to “prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilisation processes”.
The US health regulator placed “all drugs and drug products offered for import into the United States from the firm on import alert“.
The USFDA asked the company to investigate and determine root causes of any violations, and implement corrective and preventive measures to ensure future and sustained compliance so that these violations and any others do not occur again.
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