| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesMAY 16 2011
WARNING LETTER
VIA UPS EXPRESS
Moreno Naldoni
General Manager and Co-Owner
General Project s.r.l.
Via Della Gora 15/19
50025 Montespertoli
Florence, Italy
Dear Mr. Naldoni:
During an inspection of your firm located in Florence, Italy on January 17, 2011, through January 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MC1 computerized body massager with ultrasonic diathermy. 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 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 (MDR) regulation.
We received a response from you, received February 11, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. 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, your firm has no written procedures for reporting MDR events to the FDA.
We reviewed your response and conclude that it is not adequate. You provide CAPA AC001/11, which indicates that Quality Manual MQ Sect. 8.5.2.1, and Internal Operating Procedure POI 14.01 “Corrective actions,” have been modified and a new instruction, IOI 08.04 “Management of MDR according to FDA code of Federal regulation title 21 part 803,” has been developed, but documentation of your implementation of those procedures has not been provided. Additionally, the response does not include how you will evaluate previous complaints to determine if they should have been reported.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
U.S. federal agencies are advised of the issuance of all 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 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent this violation, or a similar violation, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. 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 of the following Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
Failure to include an agreement in purchasing documents that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device, as required by 21 CFR 820.50(b).
For example: You do not have an agreement that requires your solenoid valve supplier to provide notification of changes to specification. According to CAPA 002/10, you determined that Sirai provided solenoid valves that were model number L340V09G instead of L340V04G after you found that the valves were “noisy.” You do not have an agreement with Sirai that requires that Sirai notify you of changes to the supplied product.
We reviewed your response and conclude that it is not adequate because you only provided CAPA AC005/11, which indicates that a specific requirement regarding notification of changes will be added to each Purchase Order issued from now on and POI 06.01 “Purchasing” will be revised. You have not provided a revised version of POI 06.01 that includes a requirement for suppliers to notify you of changes to the supplied product or documentation of the implementation of such requirements. Additionally, the response does not include how you will evaluate previously purchased product to ensure that there are no other changes of which suppliers did not inform you.
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. 2622
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to CMS case #179332 when replying. If you have any questions about the content of this letter please contact: Matthew Krueger at (301) 796-5585 or by facsimile at (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.
Sincerely yours,
/s/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
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