Inspections, Compliance, Enforcement, and Criminal Investigations
Tetracore, Inc., 12/1/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
December 1, 2009
RETURN RECEIPT REQUESTED
William Nelson, Ph.D.
9901 Belward Campus Drive
Rockville, Maryland 20850
Dear Dr. Nelson:
During an inspection of your firm located in Rockville, MD on May 21 through May 28, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Redline Alert Anthrax Test kit. 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. You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
1. This inspection 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, their 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 (C.F.R.), Part 820. We received a response dated June 29, 2009, from Yuexia, Li, Ph.D., Senior Director of QA/QC, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483), that was issued to you at the conclusion of the inspection. We address our concerns with your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
a. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 C.F.R. 820.75(a). For example, no evidence was provided to show that you had validated the lyophilization process used to dry the positive controls of the Redline Alert Test kit.
We have reviewed your response and have concluded that it is inadequate because you did not submit the process validation protocols.
b. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. 820.1 98(a). For example, a written complaint handling procedure was not provided when requested by the FDA investigator.
We have reviewed your response and have concluded that it is inadequate because you did not provide a copy of the procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
c. Failure to establish and maintain adequate procedures to control the design of a device in order to ensure that specified design requirements are met, as required by 21 C.F.R. 820.30. Specifically, Standard Operating Procedure (b)(4) provided by the firm as their design control procedure, is inadequate. For example:
i. The Design Control Program procedure does not include a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 C.F.R. 820.30(c).
ii. The Design Control Program procedure does not ensure that design reviews include an individual(s) who does not have direct responsibility for the design stage being reviewed, as required by 21 C.F.R. 820.30(e). Additionally, when requested, you did not provide evidence that an individual who does not have direct responsibility for the design stage participated in the design review meetings for the Redline Anthrax Alert Test kit.
We have reviewed your response and have concluded that it is inadequate because you did not provide a revised procedure meeting these requirements and evidence of a new design review, to include an independent reviewer.
2. Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information concerning the device that is required by or under section 519 of the Act, 21 U.S.C. 360(i), and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. 803.17. For example, a written MDR procedure was not provided when requested, by the FDA investigator.
We have reviewed your response and have concluded that it is inadequate because you did not include a copy of the written MDR procedures and documentation that the MDR procedures are implemented and maintained.
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 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, 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: Nancy Rose, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about the content of this letter please contact Ms. Rose at (410) 779-5415.
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. The specific violation(s) noted in this letter and in the FDA 483, issued at the conclusion 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.