The US Food and Drug Administration (USFDA) has sought to come down heavily on Aurobindo Pharma with regard to the current good manufacturing practice (CGMP) compliance levels at a few of its facilities.
In a warning letter that it issued recently to the firm, post inspection of its active pharmaceutical ingredient facility (Unit XI) in Andhra Pradesh’s Srikakulam district, the FDA pointed out that CGMP observations similar in nature were also observed 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,” it said. Such repeated failures at multiple sites, the USFDA said, “demonstrate that management oversight and control over the manufacture of drugs are inadequate.”
On June 21, intimating the stock exchange about receipt of the warning letter for Unit XI, the firm said the USFDA had inspected the site in February. The company also had mentioned that the existing business from the facility would not be impacted.
Summarising significant deviations from CGMP for API, the warning letter said since “your methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP, your APIs are adulterated within the meaning” of U.S. laws. The letter said “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” at the Unit XI.
Earlier, in May, the USFDA had issued letter to Aurobindo Pharma classifying its inspections at the company’s API facilities of Unit I and XI and intermediates facility of unit IX in February as official action indicated (OAI).