Medical device manufacturer Integra LifeSciences Holdings Corp. was on the receiving end of a warning letter from the U.S. Food & Drug Administration last week, in which it was cited over concerns relating to process validations, corrective and preventative actions, as well as document controls, at its Añasco plant.
The warning letter related to quality systems issues resulted from an inspection conducted at that facility during October and November 2012.
The Añasco facility manufactures and finishes products that accounted for approximately 18 percent of the company’s consolidated revenues in 2012. Those products include many of its regenerative medicine collagen products, including Duragen Dural Graft Matrix.
The FDA’s warning letter includes, among other things, a request that Integra “prevent the distribution of collagen products manufactured at [the] Añasco site that do not have successful and complete validation studies.”
In response, on Feb. 15, the company stopped distribution of its collagen products manufactured in the Añasco facility to confirm that it had successfully validated them, and engaged a third-party consultant having appropriate quality system regulations expertise to confirm such validations, the company said in documents filed with the Securities and Exchange Commission Tuesday.
“Integra believes that it has already substantially remediated the issues addressed in the warning letter and is having third-party consultants assess its procedures and processes to ensure that products are manufactured in accordance with applicable regulations, as recommended by FDA,” it said in a statement, adding the validation process should be completed by Feb. 26, after which it will resume distributing the products in question.
Furthermore, the company — which can produce most of the mentioned products in its Plainsboro, New Jersey facility — also said it has reviewed the complaint history of the affected products and confirmed there is no indication that any distributed products pose a risk to patients.
This is the second time since 2011 that the FDA has pointed out flaws at the Integra plant in Añasco.
“The company takes this matter seriously. Any further actions by the FDA could have a material adverse impact on our financial position and operating results. The Company intends to implement corrective actions to address the concerns identified in the warning letter,” Integra told the SEC.
“The company cannot, however, give any assurances that the FDA will be satisfied with its response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter,” it added. “Until the violations are corrected, the company may be subject to additional regulatory action by the FDA, including seizure, injunction and/or civil money penalties.”