Unexo Lifesciences Faces USFDA Heat Over Serious CGMP Violations
In response to the issues, the USFDA recommended a voluntary recall of all drug products manufactured at Unexo's facility for the U.S. market.
New Delhi: The United States Food and Drug Administration (USFDA) issued a Warning Letter to Unexo Lifesciences, Private Limited, an Indian drug manufacturer, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The inspection, conducted in May 2024, revealed serious issues with data integrity, quality control, and facility maintenance.
The USFDA found evidence of manipulated da records, incomplete laboratory results, and unauthorized access to computer systems, which cast doubts on the reliability of the data supporting the safety and effectiveness of Unexo’s drugs.
Additionally, the company was cited for inadequate documentation in batch production records, missing raw data for product testing, and insufficient oversight by the quality control unit. These quality control lapses raised concerns about the consistency of the drugs.
The Administration also noted unsanitary manufacturing conditions, including unclean air conditioner vents above production areas that could lead to contamination of drugs.
Also Read: Zydus Lifesciences gets warning letter from USFDA for Jarod facility
In response to these issues, the USFDA recommended a voluntary recall of all drug products manufactured at Unexo's facility for the U.S. market. Unexo has committed to the recall, but the details are still pending. The USFDA also ordered a suspension of production for the U.S. market until corrective actions are taken, warning that future drug products from Unexo may be refused entry into the U.S. if these violations are not addressed.
Unexo has acknowledged the violations and is conducting an investigation into the issues. The company has hired a third-party consultant to assist with addressing the data integrity problems. However, the USFDA has deemed Unexo's initial response insufficient and has requested a more comprehensive plan for remediation.
Medical Dialogues team had reported a few months ago that the US Food and Drug Administration (USFDA) had issued a warning letter to Aurobindo Pharma for Unit-III, a Formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana.
Also Read: USFDA issues warning letter to Aurobindo Pharma arm Unit III
