| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
SEP 26, 2011
WARNING LETTER
VIA UNITED PARCEL SERVICE
Mr. Konrad Kobel
Vice President for Quality Management/Regulatory Affairs
Aesculap AG
Am-Aesculap Platz
Tuttlingen, Germany 78532
Dear Mr. Kobel:
During an inspection of your firm located in Tuttlingen, Germany on May 16, 2011, through May 19, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Craniofix, Yasargil Titanium Alloy Aneurysm Clip, S4 Cervical Occipital Plate Spinal System, and Vega Knee System. 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.
Our inspection revealed that your Yasargil Titanium Alloy Aneurysm Clips are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting.
We received a response from you dated June 1, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR Part 803.17.
For example: Your firm’s procedure does not include the requirements for submission of MDRs to FDA. Your firm’s procedure, (b)(4) as written, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, a standardized review process or procedure for determining when an event meets the criteria for reporting, timely transmission of complete medical device reports, and documentation and recordkeeping requirements, as required by 21 CFR Part 803.17.
We reviewed your firm’s response dated June 1, 2011, and conclude that it is not adequate. Although you provided an English translation of your firm’s procedure, (b)(4) it does not meet the requirements of 21 CFR Part 803.17 as stated above.
Federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820.
We received responses from you dated June 1, 15, 17, and 30, 2011, concerning our investigator’s observations noted on the FDA 483 that was issued to your firm. These nonconformities include, but are not limited to, the following:
- Failure to adequately confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). (b)(4)
The adequacy of your firm’s response dated June 1, 2011, cannot be determined at this time because your firm did not include objective evidence that the (b)(4) that would provide objective evidence that these procedures are in place and being utilized, were not included for review.
- Complaints involving the possible failure of the device to meet any of its specifications have not been adequately investigated as required by 21 CFR 820.198(c). For example: The firm received five complaints (400060307, 400079122, 400079146, 400088744, and 400090631) that described the detachment of the top half of Craniofix (Material numbers FF90T, FF491T, and FF92T) device after the pin was cut. Complaint investigation records indicate the failure may be associated with an angled cut of the pin. It does not appear that an investigation was conducted.
The adequacy of your firm’s response dated June 15, 2011, cannot be determined at this time. Your firm’s response did not include objective evidence (b)(4)
The adequacy of your firm’s response dated June 30, 2011, cannot be determined at this time. Your firm’s response did not include objective evidence (b)(4)
- Failure to establish and maintain adequate procedures to control environmental conditions where they could reasonably be expected to have an adverse effect on product quality have not been established and maintained, as required by 21 CFR 820.70(c). For example: (b)(4)
The adequacy of your firm’s response dated June 1, 2011, cannot be determined at this time. Your firm’s response does not indicate that the employees that utilize (b)(4) were trained on the new procedure. Also it is not clear if there was training conducted (b)(4) for the measurement of the differential pressure using the newly installed pressure hoses.
Your firm’s response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number 205233 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter at (301) 796-5587 or fax at (301) 847-8139.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health
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