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  5. Ralco S.R.L. - 415275 - 12/06/2013
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Ralco S.R.L. MARCS-CMS 415275 —

Delivery Method:
Medical Devices

Recipient Name
Mr. Giovanni Pagani
Recipient Title
Quality Assurance Manager
Ralco S.R.L.

Via Dei Tigli 13/g
20046 Biassono MI

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


December 6, 2013

RE: FDA Reference Number: CMS 415275

Dear Mr. Pagani:

During an inspection of your firm, located in Biassono, Milano, Italy on 7/08/2013 through 7/12/2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Ralco Model R108 x-ray collimator. 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 the Ralco collimator 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 an undated response from Mr. Giovanni Pagani, Quality Assurance Manager, on 7/12/2013 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. These violations include, but are not limited to, the following:

Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, during the inspection of your firm, it acknowledged that it does not have an MDR procedure.

We reviewed your firm’s undated response to the FDA 483 and conclude that it is not adequate. After reviewing your firm’s MDR procedure MDR-001-01 titled “Reports to Agencies (Includes MDR Reporting),” Rev. No. 0, dated July 30, 2013, the following issues were noted:

1. MDR-001-01, Rev No 0, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:

a. The procedure does not include definitions from 21 CFR 803.3 for the term “caused or contributed,” and the definition for the term “reasonably suggests,” found in 21 CFR 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).

2. MDR-001-01, Rev No 0,does not describe how your firm will address documentation and record-keeping requirements, including:

a. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.

b. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

In addition, your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).

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 Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov

Also, 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 adequate procedures for validating the device design as required by 21 CFR 820.30(g). For example, your firm’s collimator model R225 has a printed circuit board, (b)(4), which operates using computer software. The software used by (b)(4) is used to control the movement and position of the collimator’s aperture. As per your firm’s documentation, (b)(4), your firm validated the software on 03/28/2009. However, when asked to provide the software validation protocol, validation data, and any software validation/verification tests conducted, your firm stated that the results of the software validation activities are not documented nor maintained in the design history file.

The response dated 7/12/2013, is not adequate. Your firm provided Document No (b)(4) titled ‘”FDA Software Validation” which states the proposal to “provide a copy of the procedure to the software suppliers to inform them about the correct management of the development, the verification and the validation of the software.” However, the response provides neither a copy of the validation protocol which the software suppliers should follow nor the results of tests conducted or validation data to confirm that the software on the R225 device was adequately validated.

In addition, FDA has noted nonconformances with regards to Part C (Section 531-542) of the Act (21 U.S.C. § 360(hh)-360(ss)), which are deficiencies within your firm’s Electronic Product Radiation Control program specified in the Electronic Product Radiation Control regulation found at 21 CFR Subchapter J. These nonconformities include, but are not limited to, the following:

1. Failure to submit an annual report by the September 1 due date, as required by 21 CFR 1002.13(b). Specifically, the Annual Report for the July 1, 2010 - June 30, 2011 time period was submitted on October 20, 2011 (Document Number (b)(4)). Also, the Annual Report for the July 1, 2011 – June 30, 2012 time period was submitted on September 28, 2012 (Document Number (b)(4)).

The response dated 7/12/2013 appears to be adequate. Your firm provided documentation of modification to the “FDA Annual Report” procedure. This document was approved using your firm’s document control procedures. Your firm admitted not being aware of the September 1 deadline, and have now integrated that deadline into your Annual Reporting procedures.

Your firm’s response to this letter should clearly identify the FDA reference numbers, CMS case# 415275 and CTS# COR13000395, and be sent to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
OIR - Division of Radiological Health
Attn: Diagnostic X-Ray Systems Branch
Document Mail Center -- WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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.

If you have any questions about the contents of this letter, please contact: James L. Woods, Deputy Director for Patient Safety and Product Quality at (301) 796-6225 or fax at (301) 847-8514.

Sincerely yours,

Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

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