Inspections, Compliance, Enforcement, and Criminal Investigations
Fuji System Corp 18-Aug-08
Department of Health and Human Services
Public Health Service
Center for Devices and
AUG 18 2008
VIA FEDERAL EXPRESS
Mr. Yoichiro Kawaguchi
Fuji System Corp
23-14, Hongo 3-Chome, Bunkyo-ku
Dear Mr, Kawaguchi:
During an inspection of your firm located in Tokyo, Japan on April 7, 2008, through April 9, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Silbroncho, USA Uniblocker and the Phycon Silicone Foley Balloon Catheter. 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 a response from Mr. Takuya Oshiro dated May 14, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that 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 validate a process whose results cannot be fully verified by subsequent inspection and testing, as required by 21 CFR 820.75(a). For example, some processes have not been validated and others have not been adequately validated according to established procedures. Specifically, the silicone tubing extrusion and vulcanization processes have not been validated. In addition, the package sealing process validation lacks established pressure limits.
We have reviewed your response and have concluded that it is inadequate because it only confirms the need to conduct further validation of the processes identified by the investigator and provides an expected correction date of September 2008 for the validation of the silicone tubing extrusion and vulcanization process and the package sealing process. In addition, the response did not address any retrospective review of other processes that may need process validation or a review of other completed process validations for assurance of its completeness. Your firm should submit documentation that includes a description and evidence of the implementation of the correction, the corrective action, and any proposed preventive action in regards to the process validation observations. Preventive action measures should include a retrospective review of processes that may need validation and a review of completed process validations. When procedures are submitted in response to this deficiency, the portion relating to correcting this observation should be translated into English.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm's CAPA procedures do not include provisions to verify/validate that the corrective/preventive action taken is effective and does not adversely affect the finished device.
We have reviewed your response and have concluded that it is inadequate because it only confirms the need to revise your CAPA procedures and it provides a correction completion date of May 2008. Your firm should submit revised CAPA procedures that include provisions to verify/validate that a corrective/preventive action taken is effective and does not adversely affect the finished device. When procedures are submitted in response to this deficiency, the portion relating to correcting this observation should be translated into English.
3. Failure to ensure that calibration procedures include specific directions and limits for accuracy and precision, as required by 21 CFR 820.72(b). For example, the temperature gauges used for monitoring the package sealing equipment are not calibrated using limits for accuracy. Specifically, during calibration, temperatures exhibited on sealing apparatuses range from less that [(b)(4)] to greater than [(b)(4)] however, there is no indication as to which temperature ranges are acceptable to ensure monitoring gauges are operating with calibration standards.
We have reviewed your response and have concluded that it is inadequate because it only states that validation of the heat sealer used on sterilized packaging is conducted [(b)(4)] and provides a correction completion date of June 2008. Your firm should submit documentation as evidence of the implementation of the correction and the corrective action that demonstrates that the temperature gauges used for monitoring package sealing equipment were calibrated using limits for the accuracy. When procedures are submitted in response to this deficiency, the portion relating to correcting this observation should be translated into English.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. 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 violations, 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. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: William MacFarland, Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement B, Cardiovascular and Neurological Devices Branch, 2094 Gaither Road, Rockville, Maryland 20850 USA. If you have any questions about the content of this letter please contact: Charles Cathlin at (240) 276-0281 or FAX (240) 276-0129
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 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.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and