Inspections, Compliance, Enforcement, and Criminal Investigations
Millennium Biotechnology, Inc. 1/12/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
January 12, 2009
VIA FED EX
Paul Reiter, President
Millennium Biotechnology, Inc.
90-11 Colin Drive
Holbrook, NY 11741
Ref.: NYK 2009-08
Dear Mr. Reiter:
During an inspection of your firm located at 90-11 Colin Drive, Holbrook, NY, on September 2, 5, and 18, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures in-vitro diagnostic tests called S. typhi Rapid Test (S. typhi) and TB Plus (recombinant) Rapid Test (TB Rapid). 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 inspection revealed that the S. typhi and TB Rapid in vitro diagnostic tests 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), because you did not notify the agency of your intent to introduce the devices 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 CFR 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.
This inspection also revealed that these devices are 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, its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish Quality System procedures for the manufacture of the S. typhi and TB Rapid Tests as required by 21 CFR § 820.20(e). Specifically, when the investigators asked you for documentation of these procedures, you provided none. You provided no evidence that you complied with 21 CFR § 820.20(e).
2. Failure to maintain records for these devices as required by 21 CFR § 820.180. Specifically, when the investigators asked you for these records, you claimed they were either shredded or never maintained by you.
3. Failure to maintain device master records for the manufacture of S. typhi and TB Rapid Tests as required by 21 CFR. § 820.181. Specifically, when the investigators asked you for these records, you claimed they were either shredded or never maintained by you.
4. Failure to maintain device history records for the manufacture of S. typhi and TB Rapid Tests as required by 21 CFR § 820.184. Specifically, when the investigators asked you for these records, you claimed they were either shredded or never maintained by you.
Please note that the S. typhi and TB Rapid Tests are "finished devices" under 21 CFR § 820:3(1) because, as manufactured by you, they are suitable for use or capable of functioning. Moreover, although you claim the tests are "For Research Use Only," there is no evidence that they were labeled that way. See 21 CFR § 809.10(c)(2)(i).
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 FDA 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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) 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 directed to Richard T. Trainor, Compliance Officer, U.S. Food and Drug Administration, 300 Hamilton Ave., White Plains, New York 10601. If you have any questions about the content of this letter, please contact Mr. Trainor at 914-682-6166 x34.
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 FDA 483 issued at the closeout of the 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.
Otto D. Vitillo