Inspections, Compliance, Enforcement, and Criminal Investigations
Lucomed Spa 2/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
FEB 23 2012
VIA UNITED PARCEL SERVICE
15 Via Emilia Romagna
During an inspection of your firm located in Carpi, Italy on September 19, 2011, through September 22, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures plastic components and accessories to hemodialysis blood lines. 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 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 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.
We received your firm’s response dated October 10, 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 and nonconformances. These violations and nonconformances 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, during the inspection, your firm acknowledged not having developed a written medical device reporting (MDR) procedure. The MDR regulation defines ''manufacturer" to include any person who ''manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is ... " (21 CFR 803.3). Your firm markets medical device components as “universal” accessories that are intended for use with many different medical devices. Therefore, your firm meets the definition of a medical device manufacturer and is required to comply with the medical device reporting requirements of 21 CFR Part 803. During the inspection, your firm acknowledged not having developed a written MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided an MDR Procedure entitled (b)(4) dated September 13, 2011. This procedure describes the reporting process for Elcam Medical to FDA. However, the procedure does not describe the process that Lucomed S.p.a. will follow to communicate adverse events associated with devices marketed by Lucomed to Elcam Medical A.C.A.L., in order for Elcam to evaluate adverse events for reporting to FDA.
If your firm wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or other MDR-related topics, it may contact FDA’s MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@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.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that 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 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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies pertaining to current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These nonconformances include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, (b)(4), was identified as the procedure for handling complaints, non-conformances and corrective and preventive action; however, this procedure does not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, and other sources of quality data to identify existing and potential causes of non-conforming product or other quality problems.
The response dated October 10, 2011, appears to be adequate.
2. Failure to establish and maintain adequate procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, (b)(4) Regulations for Access to Controlled Areas, was not being implemented. (b)(4) If the procedures were followed, (b)(4)
The adequacy of the response dated October 10, 2011, cannot be determined at this time. While the response to this observation appears adequate, 2 of the 3 pieces of supporting documentation are in Italian. The two pieces of documentation that are in Italian: (1) the personnel training records; and (2) a copy of the October 7, 2011, audit report. Please submit English translations for these two documents.
Your 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 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #257195 when replying. If you have any questions about the contents of this letter, please contact: Mr. Paul F. Tilton at 301-796-5770 or (fax) 301-847-8137.
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