Integra LifeSciences get warning letter from FDA

Integra LifeSciences has received a warning letter from the FDA with regards to quality system problems at a Boston-area plant that makes extracellular bovine matrix products to treat chronic wounds.

Whilst the warning letter is not anticipated to have a financial impact on the company or restrict or prevent it from making or selling products (the plant accounted for less than 4% of Integra’s sales in 2018), Integra have said in a regulatory filing that they “take the matters identified in the letter seriously” and have “undertaken significant efforts to remediate the observations and continues to do so” since the FDA inspection of its plant in October and November 2018 when a Form 483 was raised with respect to the findings. Integra is preparing a response to the subsequent warning letter having already submitted meticulous monthly reports on its corrective actions.