Integra LifeSciences Gets FDA Warning Letter On Puerto Rico Facility
February 20th, 2013 // 5:20 pm @ jmpickett
Integra LifeSciences Holdings Corp. ( IART) announced that on February 14, 2013, it received a warning letter from the United States Food and Drug Administration or FDA related to quality systems issues at its manufacturing facility located in Añasco, Puerto Rico. The letter resulted from an inspection conducted at that facility during October and November 2012.
The warning letter cites concerns relating to process validations, corrective and preventative actions, and document controls.
The company said it believes that it has already substantially remediated the issues addressed in the warning letter, and is in the process of having third-party consultants assess its procedures and processes to ensure that products are manufactured in accordance with applicable regulations, as recommended by FDA.
The company noted that Añasco facility manufactures several of its collagen products, including Duragen Dural Graft Matrix and several OEM products sold to strategic partners through its Private Label business. Sales of products manufactured or packaged in the Añasco, Puerto Rico facility constituted approximately 18% of Integra’s consolidated revenues during 2012.
The company stated that it also has the capability to produce most of the relevant products in its Plainsboro, New Jersey facility.
