Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year

14 May 2024
www.fiercepharma.com
Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year
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Source: FiercePharma
Aurobindo's Eugia unit continues to be scrutinized by the FDA, racking up a fifth Form 483 since December.
Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December.
The company’s latest slap from the U.S. regulator stems from an April 25 to May 3 inspection of its Bhiwadi sterile drug manufacturing unit in Rajasthan, India, which resulted in seven observations.
The majority of the observations were related to workers not following procedures that are intended to prevent microbial contamination or the site lacking manufacturing processes to prevent contamination.
In the first observation cited by the FDA, inspectors observed on several occasions operators performing a “manual intervention” by reaching over an aseptic line with their arms and upper torsos, blocking air flow.
Such actions, the agency said, were observed in a July 2022 inspection that was determined to be the “root cause of a contaminated vial and subsequent media failure.”
The facility was also cited for failing to have procedures in place that are designed to prevent contamination of drug products and for not thoroughly reviewing unexplained manufacturing discrepancies and batch failures. The facility produces sterile drug products that are sent to the U.S. and European markets.
Prior to this FDA rebuke, Eugia sites in India received FDA Form 483 citations in April and twice in February, FDA records show. In December, the agency handed down a citation for a plant in New Jersey that Aurobindo has since agreed to sell.
Separately, in early April, Eugia issued a voluntary recall of one lot of the muscle relaxant methocarbamol injection after a customer complained of finding white particles inside a vial.
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