FDA slams Eugia with Form 483 and posts older reprimands for AGC, Baxter

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来源: FiercePharma

The FDA hit Aurobindo subsidiary Eugia US with a Form 483 and posted manufacturing write-ups for several other companies.

Aurobindo subsidiary Eugia US received an FDA Form 483 write-up following a recent manufacturing inspection that turned up 10 observations at the company’s facility in New Jersey, including issues with a construction project posing a contamination risk.

The agency conducted its Eugia inspection from Dec. 11 to Dec. 22, according to the document. During the visit, the agency noticed "construction activities" in a warehouse and near the firm's microbiology lab, among other areas, according to the FDA's filing.

The inspection also uncovered damage to an HVAC system located near a classified aseptic processing line, plus what “appeared to be damage caused by ceiling leaks” located next to the company's aseptic processing area.

The FDA said Eugia lacked quality control documentation to prevent any contamination, as well.

Besides Eugia, the FDA this week posted older Form 483 filings for AGC Biologics and Baxter. Alvotech was also included in the latest batch of Form 483 disclosures by the FDA, but that company had previously revealed its own manufacturing shortfalls.

In AGC's Form 483, the company's plant in Bothell, Washington, was cited with five observations after an inspection in February 2023. The write-up mainly focused on inadequate quality control issues, procedural controls for electronic data and shortfalls with employees following standard operating procedures.

As for Baxter, the agency inspected the company's site in Ahmedabad, India, in January 2023 and then handed out a Form 483 with nine observations.

In a subsequent warning letter for Baxter over the summer, the agency cited the company for not following written procedures for cleaning and maintaining equipment among other shortfalls.

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