Integra LifeSciences (NSDQ:IART) said the FDA determined its remediation efforts at a Puerto Rico manufacturing plant flagged with a warning letter last February have been effective.
The FDA issued a Form 483 after inspections in the fall of 2012, citing concerns about process validations, corrective and preventative actions, and document controls.
Integra 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.
"At the conclusion of the inspection, the FDA found that the Company had addressed the issues raised in the Warning Letter and previous inspectional observations, and it issued no other inspectional observations. In reaching this conclusion, the FDA determined that the Company’s remediation activities were effective and its quality management system was adequate," Integra said in a regulatory filing.
The plant, located in Añasco, Puerto Rico, manufactures Integra collagen products, including DuraGen Dural Graft Matrix and OEM products sold on a private-label basis.
As of 2012, products manufactured or packaged at the Anasco facility constituted 18% of Integra’s annual revenue. At the time, the company said it had duplicate production capabilities at its headquarters in Plainsboro, N.J., which was the focus of a separate FDA warning in 2011.
For 2013, Integra reported revenue increased slightly to $836 million, but a $17 million loss that year interrupted what had been a steady stream of annual profits.