After years of back-and-forth with the FDA, AMRI ($AMRI) believes it's close to getting clear of a 2010 warning letter for its Burlington, MA, plant, completing a reinspection and preparing a final report.
AMRI bought the facility in June 2010, and the FDA handed down a warning letter just two months later, citing the company for its injectable drug contamination. After a 2011 reinspection, the agency issued a Form 483 detailing 7 problems in need of correction, and AMRI has since rectified those issues, the company said.
Finally, the FDA returned this month to confirm AMRI's work, issuing another Form 483 with three observations that are "limited in scope and nature," according to the company. Now, AMRI is preparing a response letter detailing its corrective actions and, if all goes according to plan, convincing the FDA to lift its warning letter.
"We are pleased to have the FDA inspection of our Burlington operations completed," CEO Thomas D'Ambra said in a statement. "Burlington will continue to operate without restriction while we await the FDA's disposition."
AMRI is undoubtedly glad to be nearing the end of a years-long saga with regulators. As FiercePharmaManufacturing points out, the contract manufacturer acquired the plant in its buyout of Hyaluron, lured by the promise of aseptic fill services for liquid and lyophilized products that could bolster its large-scale operations.
After the FDA's initial concerns, AMRI brought in new management to turn the facility around, and CFO Michael Nolan told investors in February that the one-time "money pit" was well on its way to contributing to revenue.
And a boost to large-scale manufacturing couldn't come at a better time. AMRI has finally steered clear of posting regular net losses each quarter, riding 14% Q2 growth in large-scale work to $6.5 million in net income, up from a $3.8 million loss in the same period last year.
- read AMRI's statement
- check out FiercePharmaManufacturing's take