Inspections, Compliance, Enforcement, and Criminal Investigations
Oculus Optikgerate GmbH 21-Feb-06
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
February 21, 2006
VIA FEDERAL EXPRESS
Mr. Rainer B. Kirchhubel
Oculus Optikgerate GmbH
Munchholzhauser Str. 29
D-35582 Federal Republic of Germany
Dear Mr. Kirchhubel:
During an inspection of your firm located in Wetzlar, Germany on September 5-9, 2005, an investigator from the United States Food and Drug Administration (FDA) detennined that your firm manufactures the Pentacam and Pachycam devices. These products are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
This inspection revealed that these devices appear to be 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 (CFR), Part 820. Significant violations include, but are not limited to, the following:
1. Failure to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual who does not have direct responsibility for the design stage being reviewed, as required by 21 CFR 820.30(e). For example, the Development Process procedure, [redacted] do not ensure that participants at each design review meeting include an individual who does not have direct responsibility for the design stage being reviewed. Design Review meeting minutes were reviewed for the Pachycam design project and only persons with direct responsibility for the design stage being reviewed was recorded as being present.
2. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements, as required by 21 CFR 820.22 For example, the firm's Systemaudit procedure, [redacted] required that all departments be audited each year. However, at the time of the inspection, the Personalwesen (Personnel) department had not been audited since December 2003. Also, the Konstruktion (Research and Development) department was not audited in 2004 and the 2005 audit was not conducted until March 24, 2005.
3. Failure to include in the device history record, acceptance records which demonstrate the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184(d). For example, 26 out of 27 Pentacam Device History Records reviewed did not include the original final acceptance results for the devices. The Device History Records for the 26 devices contained only post rework final acceptance test results.
Additionally, the above-stated inspection revealed that your devices are misbranded under section 502(t)(2) of the Act (21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish any material or information as required by or under section 519 (21 U.S.C. 360i) respecting the device and 21 CFR Part 803- Medical Device Reporting (MDR) regulation . Specifically, your firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.
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 FDA Form 483, Inspectional Observations (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. 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 government contracts.
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 all documentation of the corrective action you have taken. If you plan to make any corrections in the future, include those plans with your response to this letter as well. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement A, Dental, ENT, and Ophthalmic Devices Branch, 2098 Gaither Road, Rockville, Maryland 20850 USA, to the attention of Ronald Swann, Branch Chief. If you need help in understanding the contents of this letter, please contact Ronald Swarm at the above address or at (240) 276-0115 or Fax (240) 276-0114.
Timotfhy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health