AMRI steers clear of FDA warning letter after years of fixes

With three year's of back-and-forth with the FDA under its belt, contract drug developer AMRI ($AMRI) has finally closed the book on an agency warning letter tied to its Burlington, MA, plant, ending a protracted saga that has cost the company millions.

The facility, which houses fill and finish technologies for injectable drugs, first came under FDA fire in August 2010, just two months after AMRI acquired it in its buyout of large-scale manufacturer Hyaluron. Thus began a years-long process in which AMRI and the FDA traded corrective actions for Form 483s, culminating in the company's final response letter in July, which cleared up every issue regulators raised, CEO Thomas D'Ambra said.

"This is consistent with feedback we have received from numerous customer quality audits of our Burlington site, confirming that the corrective actions, improvements and upgrades taken at this facility provide even stronger support for our growing customer list and meet the high standards necessary to successfully operate an injectable dosage form operation," D'Ambra said in a statement. "... Moving forward, we remain committed to maintaining our uncompromising focus on quality, culture and performance at Burlington and all of our locations worldwide."

Now, with the Burlington site soon to return to full operationality, AMRI figures it can turn what CFO Michael Nolan once described as a "money pit" into a meaningful contributor to revenue. And the Albany, NY, company should have little trouble finding use for the extra capacity: AMRI counts on large-scale manufacturing sales for just over half of its net revenue, and the business hauled in $31.3 million last quarter, good for 22% growth.

Meanwhile, AMRI is headed for a period of transition come year's end, as D'Ambra plans to retire from his post after 22 years in the lead. The company is still recovering from restructuring charges and facility costs that pushed it to a $2.2 million net loss last quarter, but AMRI has strung together three consecutive quarters of revenue growth, and the company is expecting a sales increase of up to 12% for the year.

- read the announcement

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