India's Aurobindo Pharma under US FDA scanner

Indian generic drugmaker Aurobindo Pharma (BSE: 524804) has come under scrutiny from the US Food and Drug Administration (FDA) due to compliance issues detected at its formulation manufacturing facility, Eugia Unit III.

Following an inspection conducted from January 22 to February 2, the US FDA has issued nine observations regarding the facility, which specializes in producing sterile drugs such as injectables and ophthalmics.

Eugia Unit III is a part of Aurobindo Pharma's speciality business segment, known as Eugia Pharma Specialities. The observations raised in the 26-page Form 483 report highlight various concerns, ranging from procedural deficiencies to issues related to microbiological contamination prevention, incomplete laboratory records, and inadequate validation of aseptic processes.