Unexo Lifesciences Faces USFDA Heat Over Serious CGMP Violations

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