The U.S. Food and Drug Administration has issued a warning letter to a unit of Integra LifeSciences Holdings Corp. regarding manufacturing processes at its Boston facility that manufactures products for use in lab tests.
Plainsboro, N.J.-based Integra said the FDA inspected the facility in October and November 2018, and quality systems issues were identified at that time. The nature of the concerns was not described in a March 11 regulatory document announcing the receipt of the warning letter. Integra, however, said the warning letter did not contain any new observations that the company had not been aware of following the inspection.
Since then, Integra has responded to the agency to detail corrective actions taken on a monthly basis, and "significant" measures have been taken to address the agency's concerns.
The facility manufactures extracellular bovine matrix products, also known as collagen, which are used for cell cultures in laboratory tests.
Integra is a healthcare equipment company that manufactures surgical implants and medical instruments, among other products.