The FDA officially cleared Integra LifeSciences (NSDQ:IART) of violations at a plant in Puerto Rico that led to a warning letter back in February 2013.
The FDA issued a Form 483 after inspections in the fall of 2012 turned up process validations and inadequate systems for corrective and preventative actions and document controls.
In October 2014 Plainsboro, N.J.-based Integra said a follow-up FDA inspection found that the company had addressed the problems at the plant in Añasco, Puerto Rico. A Jan. 14 letter from the safety bureau to Integra made it official, according to regulatory filings.
"Based on our evaluation, it appears that you have addressed the violations contained in [the] warning letter," wrote Edwin Ramos, director of compliance for the FDA’s San Juan office, according to the filings.
Integra had said it hired 3rd-party consultants to assess its procedures and processes to ensure products manufactured at the plant were in accordance with applicable regulations.
"Over the last few years, we have made significant investments in both people and processes to enhance our global quality assurance programs," president & CEO Peter Arduini said today in prepared remarks. "The lifting of the warning letter at our Añasco facility is evidence of the progress we have made in improving our quality systems throughout the company."
The Añasco plant makes collagen products, including Integra’s DuraGen Dural Graft Matrix and OEM products sold on a private-label basis. As of 2012, products manufactured or packaged at the Añasco facility constituted 18% of Integra’s annual revenue. At that time Integra said it had duplicate production capabilities at its headquarters in Plainsboro, which was itself the focus of a separate FDA warning in 2011.