Inspections, Compliance, Enforcement, and Criminal Investigations
C Change Surgical, LLC 24-Sep-08
Department of Health and Human Services
Public Health Service
Atlanta District Office
September 24, 2008
VIA FEDERAL EXPRESS
President and CEO
C Change Surgical, LLC
101 N Chestnut Street Suite 301
Winston-Salem, North Carolina 27101-4046
Dear Mr. Kammer:
During an inspection of your firm located in Winston-Salem, North Carolina, on March 11 through March 20, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the IntraTemp™ Solution Warmer. 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 is intended to affect the structure or 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, 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 (21 CFR), Part 820. We received a response from you dated April 18, 2008, concerning our investigator's observations noted on the FORM FDA 483, Inspectional Observations, which was issued to you. 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 a design history file that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements in 21 CFR Part 820, as required by 21 CFR 820.30(j).
For example, the IntraTemp™ Solution Warmer device design history is not detailed to allow review of design/development changes as they occurred during the design process. The file lacks information about the changes which were made to the IntraTemp™ Solution Warmer, such as, bottle warmer configuration, hazard warning statements, electrical specifications and assembly housing. The dates of these changes were not included in the file.
We have reviewed your response and have concluded that it is inadequate because the device marketed has changed from the device presented in the 510(k) and your response discusses your intent to organize the design history file but does not address the changes to the device with supporting documentation.
2. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f).
For example, your firm did not confirm that the design output meets the design input requirements. Specifically, your firm did not perform design verification for all established design inputs for the IntraTemp™ Solution Warmer.
We have reviewed your response and have concluded that it is inadequate because your firm states that verification was completed. You indicated that you will re-title your documents, issue new revision numbers and restructure your document filing system. Your response failed to address verification of device design.
3. Failure to ensure that all equipment used in the manufactu ring process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g).
For example, assembly verifications and operational testing were not accomplished for the IntraTemp™ Model (b)(4) Serial No. (b)(4). Operational checks such as the (b)(4) Controller temperaure calibration, (b)(4) heater check, drainage test, (b)(4) setup check and assembly verification of the heater temperature were not performed.
We have reviewed your response and have concluded that it is inadequate because the response indicates a retest was done on the (b)(4) heater and the corrective action should include established procedures for retesting devices.
4. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released, as required by 21 CFR 820.80(d).
For example, your firm did not establish complete specifications for accepting or rejecting the finished IntraTemp™ Solution Warmer. The (b)(4) hour burn-in temperature ranges, intended to identify early premature component failures, were not established.
Your response to this observation appears to be adequate because your firm established the procedure for a (b)(4) hour burn-in for the design history with a baseline heater temperature of (b)(4) with a range of plus or minus (b)(4) A follow up inspection will be required to assure that corrections are adequate.
5. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a).
For example, instrument calibration for the (b)(4) safety analyzer was not performed. Also, your firm has not identified equipment requiring calibration and did not establish a calibration schedule as specified in the procedures.
Your response to this observation appears to be adequate because you submitted a calibration schedule. Also, the (b)(4) test equipment and the (b)(4) Analyzer were calibrated and calibration certificates were submitted with your response. A follow up inspection will be required to assure that corrections are adequate.
6. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as required by 21 CFR 820.20(c).
For example, your firm conducted one management review in October 2006. Established procedures indicate management reviews are to be performed every year. Your firm has been in business since 2004.
Your response to this observation appears to be adequate because your firm states that formal management reviews will be scheduled, held and documented. A follow up inspection will be required to assure that corrections are adequate.
7. Failure to conduct quality audits, as required by 21 CFR 820.22.
For example, your firm has not performed annual internal audits in accordance with the established procedure, Internal Audits -2.004. Audits were not conducted.
Your firm's response states that the firm will follow SOP Internal Audits - 2.004 with the first audit completed by May 7, 2008. The adequacy of this response cannot be determined at this time and the FDA will need to see evidence that audits are conducted.
8. Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
For example, there is no evidence of training for all employees who perform IntraTemp™ Solution Warming device assembly. Also, current QS regulation training is not available for employees as specified in Employee Training - 2.003.
We have reviewed your response and have concluded that it is inadequate because your firm has not provided QS regulation training to your employees.
9. Failure to review and approve changes to documents, as required by 21 CFR 820.40(b).
For example: the change control process was not initiated in accordance with established procedures, Document Control - 2.001, when changing the operator's manual for the IntraTemp™ device. The Engineering Change Notice (ECN) covering user's instructions-for-use was initiated on March 11, 2008. Changes were made to the intended use statement four months earlier on November 21, 2007.
Your response to this observation appears to be adequate because an Engineering Change Order (ECO) was initiated and your firm's management reviewed the ECO requirement with your personnel. A follow up inspection will be required to assure that corrections are adequate.
Our inspection also revealed that the IntraTemp™ Solution Warmer is 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 device is also misbranded under section 502(0) of the Act, 21 U.S.C. §352(o), because you did 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). 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 design changes made to the electrical circuitry of the IntraTemp™ Solution Warmer could significantly affect the safety or effectiveness of the device, and therefore, constitute significant changes or modifications that require a new 510(k) submission (see 21 CFR 807.81 (a)(3)(i)). These changes include:
1. A (b)(4) was added due to reports of current leakage from the device.
2. The fuse was changed from a (b)(4) fuse,
3. A user controlled temperature feature was added to the device.
4. The out of range temperature lights were modified.
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.
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 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.
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 Inspectional Observations 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.
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 sent to Serene N. Ackall, Compliance Officer at the address in the letterhead. If you have any questions about this letter, you can call Ms. Ackall at 404-253-1296.