Inspections, Compliance, Enforcement, and Criminal Investigations
Kronner Prototypes, Inc 5/9/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
May 9, 2013
In reply refer to Warning Letter SEA 13-20
Richard F. Kronner, MD, President
Kronner Prototypes, Inc. dba Kronner Medical
1443 Upper Cleveland Rapids Road
Roseburg, Oregon 97471
Dear Dr. Kronner:
During an inspection of your firm located in Roseburg, Oregon on February 1, 2013, through February 4, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Kronner Side-Kick, a Perineal Instrument Holder. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that this device is 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated February 13, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, you stated to the investigator that your firm does not have procedures governing purchasing controls. Additionally, your firm lacks a written agreement with the contract manufacturer of the sterile gas tubing your firm distributes to be used as a component on the Kronner Side-Kick.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that you will establish documentation of purchasing controls and agreements between two and six months. Your response did not state corrections your firm will initiate in the interim and you did not provide supporting documentation of actions implemented since the close of the inspection.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, you stated to the investigator that your firm does not have procedures governing corrective and preventive actions.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that you will have documented procedures in place as soon as possible; however, you did not provide a timeframe for completion and your response did not state corrections your firm will initiate in the interim. You did not provide supporting documentation of actions implemented since the close of the inspection.
3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, you stated to the investigator that your firm does not have procedures governing design changes. Since 2009, your firm has made at least two design changes to the Kronner Side-Kick, including control knob changes to eliminate gas leakage and the addition of luer guards to protect luer connectors from damage.
We reviewed your firm’s response and conclude it is not adequate. Your response does not commit to implementing design change control procedures and does not provide evidence as to why your device would be exempt from 21 CFR 820.30.
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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.
During the inspection FDA also learned that your firm was distributing the Kronner Side-Kick with indications for use as a uterine manipulator and perineal instrument holder. At that time, your firm stated it believed that these indications are covered under its Kronner Low Profile Scope device (510(k) number K973543-cleared for use in “abdominal, thoracic, arthroscopic, and nasal endoscopic surgical procedures”). However, your firm was informed that the indications for the Kronner Side-Kick, specifically for use with uterine manipulators and perineal instruments, were different than the intended use under K973543 and would require a new 510(k).
We acknowledge that during the inspection your firm stated that it would cease distribution of the Kronner Side Kick and subsequently submitted a premarket notification to the FDA. However, a review of our records reveals that your firm has not yet received the necessary clearance or approval.
It is your responsibility to ensure that all medical device products distributed by your facility are in compliance with all applicable requirements of the Act and its’ implementing regulations. You are advised that marketing a device in the United States (U.S.) without marketing clearance or approval is a violation of the Act, in that such device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), without 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). A device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), if you do 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). The FDA will take appropriate actions against manufacturers who fail to promptly take these steps. 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/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: U.S. Food and Drug Administration Seattle District Office, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. Refer to WL SEA 13-20 when replying. If you have any questions about the contents of this letter, please contact Jessica L. Kocian, Compliance Officer at 425-302-0444.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Charles M. Breen