- I.T.S. 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
JUN 30, 2014
VIA UNITED PARCEL SERVICE
President and CEO
Dear Mr. Bemsteiner:
During an inspection of your firm located in Lassnitzhoehe, Austria, on January 27, 2014, through January 30, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures
non-sterile titanium implantable plates, screws, and nails, and surgical instruments for trauma surgery. 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.
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received an unsigned, undated response from your firm on February 11, 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:
1. Failure to establish and maintain procedures for implementing corrective and preventative actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1).
For example, your firm’s Corrective and Preventive Action (CAPA) System Procedure, PD-7.6, Edition 1, does not include a requirement for analyzing quality data to identify existing and potential causes of nonconforming product, or other quality problems. Your firm has not provided evidence to show that analysis of quality data has been performed.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that SOP (b)(4) would be changed to include statistical data analysis, as well as the definition of specific events that would trigger a CAPA. However, other information, such as the revised procedure, a date for the implementation, evidence of implementation or records of completed training for the revised procedure, was not provided.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
For example, your firm has not established a nonconforming product procedure to address the identification, evaluation, segregation, and disposition of nonconforming product. Your firm’s current practice is to note the number of nonconforming products in the production record of the DHR.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that a procedure (SOP (b)(4)) will be established to include root cause analysis and a defined method of handling nonconforming product. However, other information, such as the revised procedure, a date for the implementation, evidence of implementation, or records of completed training for the revised procedure, was not provided.
3. Failure to establish and maintain procedures to ensure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
For example, your firm’s Recording of Feedback Procedure, (b)(4),(b)(4), requires an evaluation of the incident to determine whether a notification is necessary. The following four complaints lack an MDR evaluation: 07/2013, 04/2013, 02/2013, and 01/2013.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that SOP (b)(4), (b)(4), will be established to ensure that complaints are handled in a uniform manner. However, other information, such as the revised procedure, a date for the implementation, evidence of implementation, or records of completed training for the revised procedure, was not provided.
4. Failure to establish and maintain procedures to ensure that management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and sufficient frequency according to established procedures, as required by 21 CFR 820.20(c).
For example, your firm stated that it has not established a Management Review procedure. Your firm stated that the current practice is for the Quality Assurance Manager to complete the firm’s Form for the Quality Goals and for the President to review and approve it on an annual basis.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that a procedure (SOP (b)(4)) will be established to define when and with which designated individuals the formal management review will be done. However, other information, such as the revised procedure, a date for the implementation, evidence of implementation, or records of completed training for the revised procedure, was not provided.
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 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response 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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #422665 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at telephone 301-796-6110 or fax 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.
Steven D. Silverman
Office of Compliance
Center for Devices and