Inspections, Compliance, Enforcement, and Criminal Investigations
Surgical Implant Generation Network 18-Nov-08
Department of Health and Human Services
Public Health Service
November 18, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-04
Jeanne E. Dillner, Chief Executive Officer
Surgical Implant Generation Network
451 Hills Street
Richland, Washington 99354
Dear Ms. Dillner:
During an inspection of your firm located at 451 Hills Street, Richland, Washington, on July 22-23, 2008, and on August 12, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SIGN IM Nail and SIGN Fin Nail. 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.
Our 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 conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices, which are set forth in the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Your devices are also misbranded within the meaning of section 502(t)(2) of the Act (21 U.S.C. 352(t)(2)) because your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act (21 U.S.C. 360i) and the Medical Device Reporting (NIDR) regulation, 21 CFR Part 803.
The violations include, but are not limited to, the following:
Quality System Regulation
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met as required by 21 CFR 820.30(a).
Specifically, you failed to follow the design control procedures that cover the SIGN Fin Nail design. Your Design Control Procedure (SOP -004-01) identifies three forms that must be completed to ensure design requirements are met: the Design and Development Plan Form, DDP-001, Design Input Form, DIF-001, and the Design Review Form, DRF-001. You failed to complete these forms when designing the SIGN Fin Nail.
2. Failure to establish and maintain procedures for validating the device design and include risk analysis in your validation where appropriate, as required by 21 CFR 820.30(g).
Specifically, you have not conducted any risk analysis for the SIGN Fin Nail design and you could not justify why it would not be appropriate to do so. For example, you should have conducted a risk analysis when you significantly changed the design of the device and added new indications for use.
Medical Device Reporting (MDR)
3. Failure to report to FDA within 30 calendar days of receiving or becoming aware of information that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, you received Complaints PC020-06, PC014-07, PC069-07, and PC012-O8 on September 13, 2006, March 7, 2007, December 7, 2007, and February 29, 2008, respectively, but failed to submit MDR reports for these events. Complaints PC020-06, PC069-07, and PC012-08 involved nail breakage, and Complaint PC014-07 involved nail migration. All of these injuries required surgical intervention to remove or replace the broken or migrated nails.
These events represent "serious injuries," as defined at 21 CFR 803.3, that require the submission of MDRs because surgical intervention was necessary to preclude permanent impairment of a body function (walking) or permanent damage to a body structure (bone fixation/repair).
4. Failure to develop, maintain, and implement a written MDR procedure, as required by 21 CFR 803.17.
Your firm failed to develop, maintain, and implement a written MDR procedure. We acknowledge that your firm provided a written MDR procedure at the conclusion of our inspection and this corrective action appears to be adequate. We will verify the implementation of your corrective action at our next inspection.
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 administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 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.
You should take prompt action to correct the violations addressed in this letter. 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. 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 QS regulation deviations are reasonably related will not 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.
Please notify this office in writing within 15 working days of receipt of 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. Please include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include at 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.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen