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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Graftys, S.A. 6/25/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

 

June 25, 2013
 
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
 
Alain Valet
Cofounder and CEO
Graftys, S.A.
Eiffel Park – Bat C
415 rue Claude Nicolas Ledoux
Aix En Provence, France
 
Dear Mr. Valet:
 
During an inspection of your firm located in Aix En Provence, France, on March 4, 2013, through March 7, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II Bone Void Fillers. 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 BCP Bone Void Filler and HBS Bone Void Filler 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 a response from your firm dated May 27, 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 of your firm to adequately develop, maintain and implement written medical device reporting (MDR) procedures, as required by 21 CFR 803.17(a).  For example, after reviewing your firm’s MDR procedure titled, “EXIGENCES REGLEMENTAIRES USA APPLICABLES (USA Regulatory Requirements),” Version 1, dated February 27, 2008, the following issues were noted:
 
1.    Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under Part 803.  For example:
 
a.    There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b.    There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
2.    Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports.  Specifically, the following are not addressed:
 
a.    Instructions for how to obtain and complete the FDA 3500A form.
b.    How your firm will submit all information reasonably known to it for each event.
c.    The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
 
We reviewed your firm’s response and concluded that it is not adequate.  Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under Part 803.  Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports.
 
Your firm’s MDR procedure references baseline reports and annual certifications. Baseline reports and Annual Certifications are no longer required and all references to a Baseline Report and Annual Certification should be removed from the firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008, and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final Rule).
 
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
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 ReportabilityReviewTeam@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, 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 (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 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 nonconformances include, but are not limited to, the following:
 
1.    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  For example, your firm’s complaint form does not specifically require an evaluation to determine whether the event is reportable to FDA under 21 CFR 803.
 
The adequacy of your response cannot be determined at this time. Your firm stated that its “Treatment of Complaints and Management of CAPA” procedure would be updated to include the requirement of documenting whether a complaint represents an MDR reportable event and a flowchart to facilitate the decision.  However, your firm did not indicate that the complaint form would be updated to include MDR reporting requirements.  Additionally, your firm did not provide any detailed description and evidence of correction and/or corrective action, which should include the review of all of its complaints to determine if they are MDR-reportable events.
 
2.    Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that, when changes occur, the sampling plans are reviewed, as required by 21 CFR 820.250(b).  For example, your firm has not developed sampling plans based on a statistical rationale to ensure that sampling methods are adequate for its in-process and finished-product testing procedures, including its sterility sampling procedure.
 
The adequacy of your firm’s response cannot be determined at this time.  Your firm stated that it would review all sampling plans and justify the rationale for each.  Your firm also stated that it would ensure that its sampling plan development would not be limited to in-process and finished products.  However, your firm did not provide any detailed description and evidence of implementation of the corrections and/or corrective actions.
 
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 CMS case # 396846 when replyingIf you have any questions about the contents of this letter, please contact: Matthew C. Krueger, at 301-796-5585.
 
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 FDA 483 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