- o.m.t. Oberflachen - und Materialtechnologie Gmbh
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
AUG 5, 2014
VIA UNITED PARCEL SERVICE
o.m.t. Oberflachen- und Materialtechnologie GmbH
Dear Mr. Repenning:
During an inspection of your firm located at 7 Seelandstrasse, Lubeck, Schleswig-Holstein, Germany, on April 22, 2014, through April 24, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures orthopedic devices (bone screws) and manual instruments. 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 to affect the structure or function of the body.
Our inspection revealed that your firm’s 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 material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.
We received a response from Richard Csaszar, Leader of Quality, dated May 8, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 803.17. For example, at the time of the inspection, your firm was unable to provide written MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm has an adverse event procedure; however, the procedure was not provided to the FDA investigator at the time of inspection. Our office has not yet received a copy of the procedure.
U.S. 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 (which must address systemic problems) 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. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm’s complaint handling procedure, Procedural Instructions Customer Complaint, (b)(4), is deficient. Specifically, the procedure does not set the requirement for promptly reviewing, evaluating, and investigating complaints that represent an event that must be reported to FDA under part 803, Medical Device Reporting.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm has an adverse event and complaint processing procedure, but they were not provided to the FDA investigator at the time of inspection. Our office has not yet received a copy of these procedures
2. Failure to document, for validated processes, the monitoring and control methods and data, the date performed, and where appropriate, the individualss performing the process or the major equipment used, as required by 820.75(b)(2).
For example, at the time of the inspection, your firm was unable to provide the validation report for the (b)(4) process conducted per (b)(4)
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that studies related to (b)(4) were conducted in 1991. Your firm is in the process of locating the validation report and plans to send us a copy of this report. However, your firm’s response did not address whether a retrospective review was performed to identify whether similar deficiencies exist for other processes requiring validation.
3. Failure to document results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, which shall be documented in the Design History File (DHF), as required by 21 CFR 820.30(f).
For example, your firm’s break torque verification testing for twist-off screws reviewed during Design Review (b)(4), as documented in the DHF, failed to document the test article and test methods used, dates of testing and the names of individuals performing the testing.
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to conduct additional break torque verification testing using established procedures. However, your firm’s response did not indicate when your firm expects to complete the verification testing. Your firm’s response did not indicate whether a retrospective review will be performed to determine if there were similar deficiencies for design verification test reports for other devices. Your firm should submit a copy of the design verification procedures and verification testing reports.
4. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184.
For example, (b)(4) of eleven DHRs (b)(4) reviewed for Type II twist‑off screws for devices did not have a value entered for coating thickness, which is a finished product specification. At the time of inspection, your firm confirmed that sample test plates used to verify the coating thickness could not be located and that these (b)(4) batches were released without assurance that the devices met all finished product specifications.
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to train individuals who are responsible for authorizing release of medical devices. However, your firm’s response did not indicate when your firm expects to complete this training and provide documentation of the training to FDA. Your firm’s response did not evaluate risk of the released devices and whether a correction/removal of the devices in distribution would be necessary. Your firm’s response did not indicate whether DHRs for other devices will be retrospectively reviewed for similar deficiencies.
5. Failure to establish a quality plan that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured and to establish how the requirements for quality will be met, as required by 21 CFR 820.20(d).
For example, your firm’s quality manual (handbook) does not explicitly identify conformance to FDA requirements including 21 CFR 820, 803, or 806 as a requirement of your quality management system.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that your firm’s quality plan will be updated to include the conformity with the FDA requirements. However, your firm’s response did not indicate when your firm expects to complete its corrective actions and submit evidence of implementation to FDA.
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 (CMS case #432233) when replying.
If you have any questions about the contents of this letter, please contact: Mr. Daniel Walter, Chief, Foreign Enforcement Branch, via phone at 301-796-5587 or via e-mail at email@example.com
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.
Steven D. Silverman
Office of Compliance
Center for Devices and