| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human ServicesWARNING LETTER
11-PHI-21
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
September 21, 2011
Mr. Gerald R. Austin, Owner
OraWell USA
7514 Algon Ave., Apt. A
Philadelphia, PA 19111-3339
Dear Mr. Austin:
The U.S Food and Drug Administration (FDA) inspected your establishment located at 7514 Algon Ave., Apt. A, Philadelphia, PA, on June 29, 2011 and August 5, 2011. The FDA investigators determined that you manufacture in vitro diagnostic (IVD) test kits, including the OraWell Usa™ HIV 1/2 Antibody Saliva Rapid Screen Test kits which are devices within the meaning of section 201(h) [21 U.S.C. 321], of the Federal Food, Drug, and Cosmetic Act (the Act) because they are instruments intended for use in the diagnosis of disease.
Under section 513(f) of the Act, the HIV test kits 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 OraWell Usa™ HIV 1/2 Antibody Saliva Rapid Screen Test kits 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 OraWell Usa™ HIV 1/2 Antibody Saliva Rapid Screen Test kits 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.
Specifically the OraWell Usa™ HIV 1/2 Antibody Saliva Rapid Screen Test kits are 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)]. The devices are also misbranded under section 502(o) the Act [21 U.S.C. 352(o)], for failure to 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)].
For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. 360(k)], is deemed satisfied when a PMA is pending before the agency [21 C.F.R. 807.81(b)]. 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.
At the conclusion of the inspection, FDA issued you, a Form FDA 483, Inspectional Observations, that described numerous significant deviations from the Quality System (QS) Regulation. The investigators determined that you do not adhere to the QS Regulation in any manner. Therefore, your OraWell Usa™ HIV 1/2 Antibody Saliva Rapid Screen Test kits are also adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.
We acknowledge receipt of the letter dated August 31, 2011, from your attorney, (b)(4) Esquire, indicating that you will cease manufacturing OraWell USA products; it will be made part of your firm’s permanent file.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), 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: Kirk D. Sooter, District Director, Room 901 U.S. Customhouse, Philadelphia, Pennsylvania, 19106-2973. If you have any questions about the content of this letter please contact: Richard C. Cherry, Compliance Officer, at (215) 717-3075 (phone) or (215) 597-8212 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. 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.
Sincerely yours,
/s/
Kirk D. Sooter
District Director
Philadelphia District
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