Aurobindo Pharma's regulatory troubles just kicked up a notch. The FDA has sent a warning letter to the Indian pharma company, citing deficiencies at another manufacturing plant. Already under an import alert for its Unit VI facility, which makes cephalosporin antibiotics, the company now faces more scrutiny at its Unit III facility, Dow Jones reports.
The agency is demanding an action plan for improving the packaging and labeling processes at Unit III. In the letter, the FDA also offered to meet with the company to work on its compliance problems. Aurobindo has 15 days to respond. In a statement, the company said it is in the process of submitting a detailed plan and has taken the agency up on its offer of a meeting.
Already concerned about the Unit VI problems, investors were spooked by this latest FDA move against a second Aurobindo facility. Bringing one facility back into the FDA's good graces is difficult enough. "This [latest development] doesn't look good," Surajit Pal, pharmaceutical analyst at Elara Securities, told Dow Jones.
No word on whether the Unit III facility's troubles will affect Aurobindo supply partner Pfizer. The Unit VI problems are expected to interfere with Pfizer's supplies of antibiotic injections and pills, the news service says.
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