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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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C.S.O. S.R.L. 1/24/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

January 24, 2014 
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Sergio Mura
Owner
C.S.O. S.R.L.
Via Degli Stagnacci 12/E
Scandicci, Italy
 
 
Dear Mr. Mura:
 
During an inspection of your firm located in Scandicci, Italy on September 2, 2013 through September 4, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures: Biomicroscope Slit Lamps, Manual Tonometers, Powered Ophthalmic Instrument Tables, Ophthalmic Projectors, Modi Topographers, Powered Ophthalmic Chairs, Powered Ophthalmic Refracting Units, Lensmeters, AC Powered Surgical Microscopes, and Surgical Microscopes. 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 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 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.  Significant 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 was unable to provide a procedure for handling medical device adverse event reporting to the U.S. if one of your products that is distributed in the U.S. is involved in a reportable event. Once a procedure is in place, a retroactive review of complaints may be necessary to ensure all required MDR reports are submitted to FDA.
 
A follow up inspection may be required to assure that corrections and/or corrective actions are adequate. 
 
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 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.
 
Your firm’s 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 #416442 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Foreign Enforcement Branch Chief, Division of International Compliance Operations at (301) 796-5587 (telephone)or (301) 847-8138 (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. 
 
Sincerely yours,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
          Radiological Health
 
 
 
cc:
 
Giuseppe Matteuzzi
Owner
C.S.O. S.R.L.
Via Degli Stagnacci 12/E
Scandicci, Italy
 
Glida Mura
Quality and Regulatory Affairs Manager
C.S.O. S.R.L
Via Degli Stagnacci 12/E
Scandicci, Italy
 
Brett Miner
US Agent for C.S.O. S.R.L.
MDI, Inc.
501B N. Forest Road
Williamsville, NY 14221