FDA Hits Aurobindo With OAI 483
August 12th, 2024 // 1:56 pm @ jmpickett
FDA hit Indian drugmaker Aurobindo and its Eugia unit with an Official Action Indicated (OAI) 483 after a manufacturing plant inspection at the Bhiwadi facility in April 2024.
OAI is the most serious of three FDA audit recommendations, and after the company announced the 483, it said that it is committed to partner with the FDA to enhance its cGMP compliance.
OAI means that the plant didn’t meet administrative or regulatory requirements that may endanger public health. The OAI designation could cause FDA regulatory actions or approval delays.
The FDA 483 listed seven observations that were generally related to workers not following cGMP procedures designed to avoid microbial contamination. Also, the plant was cited several times for not having manufacturing processes that would stop contamination.
Several times during the inspection, FDAers noted workers were doing manual interventions by reaching across an aseptic line with their upper torsos and arms to block airflow.
The manufacturing facility was also criticized for not having procedures to stop contamination of drug products, and not completely reviewing unexplained batch failures and discrepancies. The drug plant makes sterile drugs that are sent to the European and US markets.
Before the April 483, the Eugia site also got other 483s in February. In December 2023, FDA sent a 483 for a New Jersey manufacturing facility that Aurobindo has since sold.
