The FDA hit Eugia, a unit of Indian drugmaker Aurobindo, with a classification of “Official Action Indicated” in the wake of a plant inspection at its Bhiwadi Unit II facility in April and May.
The classification, which is the most severe of the three inspection recommendations issued by the FDA, was revealed by Aurobindo in an Aug. 5 corporate announcement (PDF). Aurobindo said it "remains committed to work closely with the U.S. FDA and continues to enhance its compliance on an ongoing basis."
The OAI designation "indicates that an establishment failed to meet either regulatory or administrative requirements and may pose a hazard to public health," according to an FDA document. The designation could result in further regulatory actions or approval delays.
The designation follows a Form 483 for the plant handed down by the FDA in May. The document cited seven observations that were mostly related to the failure of employees to follow procedures intended to prevent microbial contamination as well as the facility lacking manufacturing processes to prevent contamination.
On several occasions during the inspection, FDA officials observed operators performing a “manual intervention” by reaching over an aseptic line with their arms and upper torsos, blocking air flow.
The plant was also cited for failing to have procedures in place 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.
Before the May Form 483, Eugia sites in India received FDA Form 483 citations in April and twice in February, FDA records show. In December, the agency issued a citation for a plant in New Jersey that Aurobindo has since agreed to sell.