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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Biolife, LLC 6/15/11


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

555 Winderley Place, Ste. 200
Maitland, Florida 32751

Telephone: (407) 475-4700
FAX: (407) 475-4769 




June 15, 2011

Samuel Shake
Biolife, LLC
1235 Tallevast Road
Mfg: 1249 Tallevast Road
Sarasota, FL 34243-3271

Dear Mr. Shake:


The Food and Drug Administration (FDA) has learned that your firm manufactures and distributes the non-sterile over-the-counter (OTC) product WoundSeal in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

Our investigation revealed that WoundSeal is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). WoundSeal is also misbranded under section 502(0) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). Specifically, devices classified under 21 C.F.R. 878.4018 Hydrophilic wound dressing are exempt from premarket notification. Generic devices of this type consist of materials with hydrophilic properties that are capable of absorbing exudate. However, WoundSeal includes potassium ferrate, which functions as a drug, and 21 C.F.R. 878.4018 specifically excludes wound dressings that include drugs. As such, WoundSeal employs a different fundamental scientific technology and exceeds the limitations described in 21 C.F.R. 878.9(b) and is not exempt from premarket notification. Additionally, we note that BioSeal, cleared under the name ProQR (K070520 and K080210), is (b)(4) sterilized. WoundSeal is identical in processing and composition, but is non-sterile. This change in sterilization represent a modification that could significantly impact the safety and effectiveness of a device and requires the submission of a new premarket notification. 21 C.F.R. 807.81(a)(3)(i). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Winston R. Alejo, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact Mr. Alejo at (407)475-4731.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the August 25-27, 2010 inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Emma R. Singleton
Director, Florida District