| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human ServicesWARNING LETTER
NWE-14-10W
VIA FEDERAL EXPRESS
February 26, 2010
Mr. Douglas Curtis
President
Guidewire Technologies, Inc.
26 Keewaydin Drive
Salem, NH 03079-4853
Dear Mr. Curtis:
During an inspection of your firm located in Salem, NH on January 12, 2010 through January 22, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures guidewires. 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 (C.F.R.), Part 820. We received your response dated February 11, 2010 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. Our review found that your response lacks documentation and evidence that you are implementing the corrective actions as stated. These violations include, but are not limited to, the following:
1. Failure to establish procedures to ensure that each production run, lot or batch of finished product meets acceptance criteria as required by 21 CFR 820.80(d).
Specifically, (b)(4) testing is not conducted after each sterilization process for your sterile packed guidewires. Your 510(k) submission states that finished Teflon coated guidewires will be (b)(4) free unless packaging is opened or damaged.
2. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820.75(a).
Specifically,
• The Teflon guidewire coating process has not been validated.
• The (b)(4) system installed in your manufacturing area in April 2008 has no validation data available to demonstrate that this new process has not had an adverse effect on your manufacturing operations. In addition, we observed that you have not performed any product bioburden testing since 2006.
3. Failure to conduct quality audits in accordance with established procedures to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system in accordance with 21 CFR 820.22.
Specifically, your Internal Audit SOP requires annual internal audits; however an internal audit has not been conducted on any quality system since October 2006.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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.
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 violation(s); or similar violation(s), 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: Lori A Holmquist, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have. any questions about the content of this letter please contact: Lori A Holmquist (207)622.8268 x 13.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/s/
John R Marzilli
District Director
New England District
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