Inspections, Compliance, Enforcement, and Criminal Investigations
Theken Spine LLC 03-Jan-06
Department of Health and Human Services
Public Health Service
January 3, 2006
VIA FEDERAL EXPRESS
Randy R. Theken
President of Managers
Theken Spine LLC
283 East Waterloo Road
Akron, OH 44319
Dear Mr. Theken:
An inspection of your medical device manufacturing facility conducted by our investigator on August 25 through September 9, 2005, revealed that your firm manufactures spinal implants and surgical instruments. These are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)]. The above-stated inspection revealed that your devices are misbranded within the meaning of section 502(t) (2) of the Act [21 U.S.C. 352(t)(2)] in that a report of correction or removal was not submitted to the Food and Drug Administration (FDA) as required by section 519 of the Act [21 U.S.C. 360i] and FDA's Correction and Removal Regulation, Title 21, Code of Federal Regulations (CFR), Part 806, promulgatdd under section 519. That regulation requires manufacturers and importers to promptly report to FDA, within 10 working days, any correction or removal of a device to reduce a risk to health. The following is the correction and removal that your firm did not report to FDA:
On April 4, 2005, your firm sent a Technical Bulletin to all distributors asking them to return all Torque Limiting Handle instruments for evaluation because some units may exceed the +10% tolerance, which may cause the construct (implant) to be over-tightened. This over-tightening can strip the threads. You created this bulletin because on December 16, 2004, your firm received a complaint that the threads of the locking cap had stripped while tightening the "Coral System" in the body; and your investigation revealed that the Torque Limiting Handle orthopedic instrument caused the problem.
FDA regulations require manufacturers and importers to promptly report to FDA any correction or removal of a device if the correction or removal was initiated to reduce a risk to health . See 21 CFR 806.10(a)(1). Because your firm's action described above meets the definition of a "removal" in 21 CFR 806.2(i) and because it was initiated to reduce a risk to health, your failure to report them until the issue was raised by our investigator violated 21 CFR 806.10(a)(1).
Additionally, your firm did not have a written justification for not reporting the correction and removal action to the FDA as required by 21 CFR 806.20(b)(4).
Your devices 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 manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in 21 CFR Part 820. The deviations from the QSR include, but are not limited to, the following:
1) Failure to ensure all process validation activities and results have been fully documented as required by 21 CFR 820.75(a).
Specifically, there was no sterilization validation conducted on the Torque Limiting Handle to ensure repeated sterilization does not adversely affect functionality. Your firm determined that the repeated sterilization, that this instrument is normally subject to, caused the Handle to be out of tolerance, and as a result your firm recalled this device.
2) Failure to document the design verification testing, including identification of the design, methods, date and the individual performing the verification as required by 21 CFR 820.30(f).
Specifically, design verifications for the design changes made to the [redacted] were not documented.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations. The specific violations noted in this letter and in the Inspectional Observations, Form 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 are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
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, no premarket applicationg for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct any and all deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office, in writing, within fifteen (15) working days after you receive this letter, of the specific steps you have taken to correct these deficiencies. Furthermore, please submit any additional documentation to show that you have initiated corrections. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe