The FDA completed its reinspection of Integra Life Sciences’ Añasco, Puerto Rico, manufacturing facility on Sept. 30, finding all issues raised in the February 2013 warning letter resolved, according to a Monday SEC filing.
Integra said the inspection began Sept. 4 and focused on problems cited in the warning letter and in earlier inspection of the Añasco plant. No new observations were issued during the visit.
The warning letter stemmed from an Oct. 31 to Nov. 14, 2012, inspection. Investigators from the San Juan district office found Integra’s Absorbable Collagen Sponges and Duragent Collagen products were not produced according to current good manufacturing practice and the company had failed to implement corrective and preventive actions, as required by the FDA’s quality system regulations.
Wells Fargo Securities senior analyst Larry Biegelsen called the news “positive” for Integra and “consistent with recent management comments that the company had addressed all of the FDA concerns with Añasco and made significant progress on its company-wide quality initiatives.”
Biegelsen expects the warning letter to be lifted quickly.
Integra received three warning letters in a 15-month span between December 2011 and February 2013 at its Plainsboro, N.J., Andover, UK, and Puerto Rico facilities. The Plainsboro warning letter was lifted in September 2013, and the Andover facility will be closed before the end of this year, likely preventing its reinspection. The company also shuttered its Burlington, Mass., facility this year. — Kellen Owings
