Inspections, Compliance, Enforcement, and Criminal Investigations
Sunoptic Technologies, LLC 01-Aug-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
August 1, 2007
Christopher K. Black
Sunoptic Technologies, LLC
6018 Bowdendale Avenue
Jacksonville, Florida 32216-6042
Dear Mr. Black:
During an inspection of your firm located at the above address on March 19 22, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dental Probes and light source devices, i.e., Fiberoptic Light Guides, Fiberoptic Illuminators for Endoscopes, and Light Source Fixtures/Accessories. 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.
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 (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to validate with a high degree of assurance, and approve according to established procedures, the results of a process that cannot be fully verified by subsequent inspection and test, and failure to document the validation activities and results. [21 CFR § 820.75(a)].
For example, you did not perform a validation of the cleaning and sterilization processes for Fiberoptic Light Guides to determine if the process parameters, as specified in your Sunoptics Surgical Fiberoptic Cables, Instructions For Use, Rev. F, are appropriate for the devices. Also, you did not perform a validation of the Fiberoptic manufacturing process after the equipment critical to the process was moved from its original location to a new location within your current facility, as of May 2004.
2. Failure to implement procedures to ensure the device history records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the Quality System regulation. [21 CFR § 820.184]
For example, you did not include the primary identification label and labeling used for each production unit of Dental Probe as part of the DHR for Work Order ID W027977 and W027928, in accordance with your DHR procedure, GO-008G (10/27/06). The procedure specifies, under Section 5.1.5 that "The DHR shall include, or refer to the location of the following information... primary identification label and labeling used for each production unit..." This requirement was not implemented for the above mentioned work orders.
3. Failure to document acceptance activities including the acceptance activities performed, the date acceptance activities are performed, the results, the signature of the individual conducting the acceptance activities, and, where appropriate, the equipment used. [21 CFR § 820.80(e)]
For example, you did not document the raw material issuance process to include quantity issued, date issued, and status, on Picklist Prints for work orders including Work Order ID W031554, for the manufacture of light source devices, in accordance with your DHR procedure, GO-008G (10/27/06). The procedure specifies, under Section 5.4.2 that "...All Production Work Order/Routers must have all processes completed, initialed and dated with a quantity completed or N/A where the process is not required." These requirements were not implemented for the above mentioned work order.
4. Failure to implement procedures for quality audits and conduct such audits to assure that the quality system is in compliance with quality system regulation. [21 CFR § 820.22]
For example, you did not document the dates and signature of the individual(s) conducting the audits to demonstrate that the internal audits for 2005 and 2006 have been performed, in accordance with your Quality Audits procedure, GO-023I. The procedure specifies, under Section 188.8.131.52.1 that "...Other records shall include: Audit schedules, demonstrating that internal audits have been performed and dates on which the audits were performed..." This requirement was not implemented for the above mentioned quality audits.
Our inspection also revealed that your Dental Probes 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 Dental Probes are also misbranded under section 502(o) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the Dental Probes 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.
Your Dental Probes are further misbranded under section 502(b) of the Act, 21 U.S.C. 252(b), in that the device is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor.
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.
Also, you should note that your firm's Dental Probes were not listed in accordance with section 510(j) of the Act, 21 U.S.C. 360(j). After receiving FDA premarket notification clearance for your Dental Probes, you should submit an updated Form FDA 2892 (Medical Device Listing) to the Agency.
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: Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact Mr. Schroeder at (407) 475-4763.
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, Form PDA 483 (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.
Emma R. Singleton
Director, Florida District