Cosmed S.R.L. 3/9/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 9 2012
VIA UNITED PARCEL SERVICE
00040 Pavona Di Albano
Dear Mr. Brugnoli:
During an inspection of your firm located in Rome, Italy, on May 9, 2011, through May 10, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Quark PFT Cardio Pulmonary 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 they are intended to affect the structure or function of the body.
Our inspection revealed that the Quark PFT Cardio Pulmonary System 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 Title 21 Code of Federal Regulations (CFR) Part 803 - Medical Device Reporting. We received a response fromAndrea Duca, Director of Quality Assurance, dated May 25, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), 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 803.17. For example, from the translated copy of (b)(4), entitled, (b)(4) (rev A-3; 24/10/2008), the following issues were noted:
1. (b)(4) does not establish internal systems that provide for the following:
a. Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
b. A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
c. Timely transmission of complete medical device reports to FDA.
2. (b)(4) does not describe how your firm will document and maintain records. For example:
a. Documenting and maintaining information that was evaluated to determine if an event was reportable;
b. Maintaining records of all medical device reports and information submitted to FDA; and
c. Describing a system that ensures access to information that facilitates timely follow-up and inspection by FDA.
The adequacy of your firm’s response cannot be determined at this time. The revised procedure (b)(4) (rev A-3; 23/-05/2011), is written in Italian and an English version was not included in your firm’s response.
This listing of the MDR requirements is not all inclusive. Ultimately, the responsibility rests with your firm to use its procedures effectively to comply with the requirements of 21 CFR Part 803 for determination of reportability and subsequent submission of MDRs when required.
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 to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov
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 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:
Failure to adequately document corrective and preventive action, as required by 21 CFR 820.100(b). For example:
1. The “Richiesta di azione correttiva-preventiva” CAPA report, opened on 05 November 2008 and closed on 21 December 2009, does not include a signature documenting final review and approval.
2. The “Richiesta di azione corrective-preventiva” CAPA reports, opened on 14 April 2010, 18 May 2010, and 21 May 2010, include a signature documenting final review and approval; however, these reports lack documentation of the date closed.
We reviewed your firm’s response and conclude that it is not adequate. In the response, your firm provided copies of CAPA reports with dates that coincide with the dates of the same CAPA reports collected during the inspection of your firm, which were signed but not dated by your firm’s management. However, the copies of these reports were signed and dated “22/07/2010,” “28/01/2011,” and “25/10/2010,” by your firm’s management. Additionally, as part of the systemic corrective action, your firm should have evaluated other CAPA reports to ensure that all CAPA reports have been adequately documented.
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 (EC110193) when replying. If you have any questions about the contents of this letter, please contact: Charles Cathlin, Radiology, Anesthesiology and Neurology Devices Branch Chief at (301) 796-5548 (telephone) or (301) 847-8128 (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.
Steven D. Silverman
Office of Compliance
Center for Devices and