FDA WARNING_LETTER - Biolife, LLC - August 27, 2010

On June 15, 2011, the FDA issued a Warning Letter to Biolife, LLC, for manufacturing and distributing the non-sterile over-the-counter (OTC) product WoundSeal in the U.S. without marketing clearance or approval. The FDA determined WoundSeal is a device under section 201(h) of the Act.

WoundSeal was found to be adulterated under section 501(f)(1)(B) of the Act because Biolife lacked an approved premarket approval (PMA) application or an investigational device exemption (IDE). It was also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k).

While hydrophilic wound dressings are generally exempt from premarket notification, WoundSeal contains potassium ferrate, which functions as a drug, thus excluding it from this exemption. Additionally, WoundSeal is non-sterile, unlike the cleared BioSeal (ProQR), which is sterilized. This change in sterilization represents a significant modification requiring a new premarket notification per 21 C.F.R. 807.81(a)(3)(i).

Biolife was instructed to take prompt action to correct these violations. Failure to comply could result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts and Certificates to Foreign