| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
FEB 23 2010
WARNING LETTER
VIA FEDERAL EXPRESS
Sybill Storz
Chief Executive Officer
Karl Storz Endoskope
Mittelstrasse 8
Tuttlingen D-78532
Germany
Dear Ms. Storz:
During an inspection of your firm located in Garching-Hochbruck, Germany on October 26 - 29, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures flexible video endoscopy devices. 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 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 adequately ensure that where the results of a process cannot be fully verified by subsequent inspection and test, he process shall be validated with a high degree of assurance and approved according to established procedures, a required by 21 CFR 820.75(a).
For example, the process describe in Work Instruction (b)(4) for endoscope shaft cover has not been validated.
2. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received and are documented, as required by 21CFR 820.80.
For example the test method that is used to determine the adherence of the cover to the endoscope shaft has not been validated. There is no formal SOP or work instruction for this test method.
3. Failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, the CAPA identifies at (b)(4). The CAPA lists affected instruments by product code but does not identify Product codes (b)(4) that is also affected.
4. Failure to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2).
For example the investigation of CAPA (b)(4) did not document the root cause of the non conformance. The root cause is described as "(b)(4)." This is a description of the problem but is not the root cause. Testing of product was not made to verify the failure for product manufactured according to the (b)(4) of the CAPA. Also, CAPA (b)(4) identifies the root cause as "(b)(4)". This is a description of the failure but not a documentation of he root cause of the problem.
5. Failure to document required activities, and their results, pertaining to corrective and preventive actions (CAPAs) including analysis of sources of quality data to identify existing and potential causes of no conforming products and implementation of corrective and preventive actions, as required by 21 CFR 820.100(b).
For example the short term corrective action for CAPA (b)(4) was an "(b)(4)". The corrective action did not specify a dimensional requirement for the position of the cover tube, which did not include the draft drawing for the aid of manufacturing or provide a documented training of staff performing assembly.
6. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a).
For example, the (b)(4) equipment used in the installation of the endoscope shaft cover is not established on a calibration program to ensure process conditions.
7. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements by addressing the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
For example, your firm's (b)(4) and the related work instruction (b)(4) do not address in-process identified nonconforming product. Specifically, it was found that endoscope shafts (b)(4) all failed an in-process test for leaks. These units were not controlled in accordance with SOP (b)(4). Also, shafts that fail the test for covering adherence are not subjected to SOP (b)(4). Your firm did not provide a procedure which addresses the segregation and disposition, including re-work, of nonconforming materials.
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 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. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Paul F. Tilton, W066 RM3540, 10903 New Hampshire, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact: Jeene D. Bailey at 301-796-5486 or fax 301-847-8137.
Finally, you should know that this letter is at 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.
Sincerely yours,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
Cc:
Ms. Edna Falkenberg
Director QM Systems & Regulatory Affairs
Karl Storz Endoskope
Mittelstrasse 8
Tuttlingen D-78532
Germany
No comments:
Post a Comment