Medical device manufacturer BioLife has adjusted how it makes its flagship product WoundSeal after the federal Food and Drug Administration said the product lacked a required approval. BioLife officials said the FDA had no concerns about the quality of Wound Seal, a powder that forms an instant scab over a wound. “There is no effect on the product’s safety or efficacy,” said Sam Shake, BioLife’s chief executive officer. But resolving the FDA matter is crucial for BioLife, which is awaiting FDA’s response. The company shipped about 500,000 units of its products in the last four months, twice as much as during the same period last year, and most of the growth is from WoundSeal, Shake said.
