Eugia Pharma receives a warning letter from FDA which summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
U.S. Food and Drug Administration (FDA) inspected a drug manufacturing facility of Eugia Pharma Specialities Limited (Unit III), at Patancheru (Mandal), Sangareddy, Hyderabad, Telangana, from January 22 to February 2, 2024. It is a wholly owned subsidiary of the Aurobindo Pharma.
As per FDA, The company failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. And, it failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.
Company said in a statement that there is no impact on the existing supplies to the US markets. The Company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis.
In response to the warning letter, FDA asked An independent assessment and remediation plan for the company's CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final QU decisions, and is fully supported by executive management.
