Inspections, Compliance, Enforcement, and Criminal Investigations
Akers Biosciences, Inc. 10/4/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 331-4900
October 04, 2011
United Parcel Service
Raymond F. Akers, Ph.D.
Akers Biosciences, Inc.
201 Grove Road
Thorofare, NJ 08086-2231
Dear Dr. Akers:
The U.S. Food and Drug Administration inspected Akers Biosciences, Inc., located at 201 Grove Road, Thorofare, New Jersey between April 26, 2011 and May 09, 2011. The FDA Investigators determined that you manufacture in vitro diagnostic testing kits including the Battlefield Blood Transfusion Card, which are devices within the meaning of section 201(h)(2) [USC 321] of the Federal Food, Drug and Cosmetic Act (the Act), because they are instruments intended for the use in the diagnosis of disease.
Under section 513(f) of the Act, the Battlefield Blood Transfusion Cards are class III devices, which under section 501(f)(1)(B) are deemed to be adulterated unless they have received premarket approval under section 515 or an investigational device exemption (IDE) under section 520(g). Your Battlefield Blood Transfusion Cards are not approved for sale in the United States and have not received an investigational device exemption from premarket approval. These statutory provisions protect the public health and ensure that new medical devices are safe and effective.
Additionally, this inspection revealed that you have not obtained marketing approval or clearance before you began offering the Battlefield Blood Transfusion Cards for sale, which is a violation of the law. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed. The devices are also misbranded under section 502(o) 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).
We received two written responses, dated 05/23/2011 and 05/31/2011, from your firm with corrective actions taken as a result of the inspection, however, the responses do not address premarket approval or clearance of the Battlefield Blood Transfusion Card.
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/cdrhldevadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
This letter is not intended to be an all inclusive review of the products that your firm markets. It is your responsibility to assure that your establishment is in compliance with the provisions of the FD&C Act, PHS Act, and applicable federal regulations for the products that you manufacture and distribute. You should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
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 future 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 awards and contacts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter or 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: Stephanie Durso, Compliance Officer, U.S. Food and Drug Administration, New Jersey District, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. If you have any questions about the content of this letter, please contact Ms. Durso via telephone at 973-331-4911 or fax at 973-331-4969. Please be advised that only written communications are considered official.
New Jersey District