Aurobindo Pharma pulled up by USFDA for "repeated failures" in CGMP

The FDA recently issued a warning letter to the firm after inspecting its active pharmaceutical ingredient facility (Unit XI) in Andhra Pradesh’s Srikakulam district and stated that CGMP observations were similar in nature as those made at other facilities.

Jul 04, 2019 04:07 IST India Infoline News Service

Aurobindo Pharma
The US Food and Drug Administration (USFDA) has rapped Aurobindo Pharma for repeated violations of the current good manufacturing practice (CGMP) compliance levels at its facilities. Shares of the company are currently trading flat with a positive bias.

The FDA recently issued a warning letter to the firm after inspecting its active pharmaceutical ingredient facility (Unit XI) in Andhra Pradesh’s Srikakulam district and stated that CGMP observations were similar in nature as those made at other facilities.

“Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates. These facilities are also considered to be in an unacceptable state of compliance with regards to CGMP. Such repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate,” the letter read.

The warning letter further stated, “...your methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP, your APIs are adulterated within the meaning of US laws. Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. Failure to correct the deviations may also result in FDA refusing admission of articles manufactured.”

In response to this, Aurobindo said, "We will be engaging with the regulator and are fully-committed to resolving this issue at the earliest."
 

Related Story