Eugia Hit With Another 483 in Less Than a Year
May 15th, 2024 // 10:57 pm @ jmpickett
Sterile drug manufacturing company Eugia stays under major FDA scrutiny, as the division of Aurobindo has been hit with its fifth FDA 483 since the end of 2023. The firm’s latest criticism from FDA is related to an April and May cGMP audit. The sterile drug manufacturer received seven agency observations.
Most of the 483 observations were involving employees failing to follow procedures that are supposed to prevent contamination by microbes. Also, the FDA stated that the drug manufacturing site didn’t have sufficient manufacturing processes to avoid contamination of drug products and ingredients.
In the first FDA observation, FDA inspectors said there were several times where employees engaged in a manual intervention by reaching their hands and arms over aseptic lines, which blocked air flow. These actions, which were seen in a 2022 inspection, were found to be the root cause of contaminated drug viles and a media failure.
The drug facility in India also was slapped by the US regulator for not having procedures that are intended to prevent drug products from being contaminated. It also was criticized by FDA for not going over discrepancies in manufacturing and failure of several batches. The drug facility makes sterile drug products that are delivered to markets in the EU and US.
Before the current FDA 483, other Eugia plants in India were hit with 483s in February and April of this year. Also, in December 2023, FDA cited a plant in New Jersey, which the firm has sold.
