- Tecres S.p.A.
- 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|
White Oak Building 66
Silver Spring, MD 20993
AUG 14, 2015
VIA UNITED PARCEL SERVICE
Via Andrea Doria, 6
Dear Mr. Faccioli:
During an inspection of your firm located in Sommacampagna, Italy, on February 2, 2015, through February 5, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures bone cement devices and antibiotic containing temporary spacers for knee, hip and shoulder application. 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 a response from Francesca Girardi, QA Manager, dated February 20, 2015, 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. Your firm’s responses, dated March 13, 2015, March 17, 2015, March 20, 2015, March 27, 2015, and April 2, 2015, were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. The responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm failed to qualify the (b)(4) molding and finishing processes used in manufacturing of the temporary knee (Spacer K) and hip implants (Spacer G).
The adequacy of your firm’s response cannot be determined at this time. Your firm identified a root cause and corrective action plan. Your firm states that it plans to issue a validation protocol and validate the process; however, documentation of completion of this corrective action was not included.
2. Failure to establish and maintain adequate procedures for validating the device design to ensure that the devices conform to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, your firm did not validate Excel worksheets used in design validation. Specifically, the following Excel worksheets were not validated:
a. “(b)(4); and
The adequacy of your firm’s response cannot be determined at this time. Your firm identified a root cause and corrective action plan. Your firm states that it plans to validate the Excel worksheets; however, documentation of completion of this corrective action was not included.
3. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, your firm’s finished device acceptance procedures reference risk analysis attributes severe and critical risks to process and production errors during manufacturing and control; human error; and an ineffective process. These critical attributes for final visual inspection include holes, pits, cracks, and foreign material identified on or in the device. However, there are no documented acceptance criteria for these device attributes.
Your firm’s response did not address this violation.
Our inspection also 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 regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
4. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm’s document titled “Feedback Information Customer Satisfaction - Post - Market Vigilance,” P06 REV06,-18/12/14, is not an MDR procedure. As written, under Section 1, the procedure is intended to analyze feedback information in order to evaluate product conformity, customer satisfaction, and define responsibilities and modalities.
The adequacy of your firm’s response, dated February 20, 2015, cannot be determined at this time. Your firm identified a root cause and corrective action plan; however, it does not address the observation, and an MDR procedure was not included in your firm’s response.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
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.
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. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 459252 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1(240)402-4020 (phone) or +1(301)847-8139 (fax).
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
Brauer Device Consultants, LLC.
7 Trail House Court
Rockville, MD 20850