|Issuer:||Center for Devices and Radiological Health|
|Issued:||Sept. 17, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Center for Devices and
VIA FEDERAL EXPRESS AND FACSIMILE
SEP 17 2008
John M. Paes
6199 AE Maastricht-Airport
Dear Mr. Paes:
During an inspection of your firm located in Maastricht, The Netherlands, on June 9, 2008, through June 12, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Diagnostic Electromyograph Needles, Radiofrequency Lesion Probes, Needle Electrodes, Cutaneous Electrodes, and Nasopharyngeal Electrodes. 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. These violations include, but are not limited to, the following:
1. Failure to validate and approve a manufacturing process with a high degree of assurance according to established procedures, as required by 21 C.F.R. 820.75(a). For example, the spot welding process, which utilized the [(b)(4)] Spot Welder [(b)(4) ], had no documented evidence of Installation Qualification (IQ) or Performance Qualification (PQ) prior to placing the machine into production.
2. Failure to document corrective and preventive action activities, as required by 21 C.F.R. 820.100(b). For example, there was no documentation of Corrective and Preventive Action activities for three complaints [(b)(a)] , and for four cases of nonconformance [(b)(4)] where a CAPA record was created.
3. 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, there was no calibration procedure for [(b)(4)] and no documentation that this spot welder was calibrated prior to being placed into production.
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
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)). In addition, 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 violations, from occurring again. Include documentation of the corrective actions 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 C. MacFarland, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B(HFZ-341), Office of Compliance, 2098 Gaither Road, Rockville, Maryland 20850. If you have any questions about the content of this letter please contact Mr. MacFarland at 240-276-0293 or FAX 240-276-0325.
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 he 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