Inspections, Compliance, Enforcement, and Criminal Investigations

Novastep 7/28/16

  

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 

 

WARNING LETTER 
 JUL 28, 2016
 
VIA UNITED PARCEL SERVICE
 
Grégory Glédel
Chief Executive Officer and President
Novastep SAS
espace Performance-Alphasis
Bâtiment C1-C2
35769 saint-gréoire
france
 
Dear Mr. Glédel:
 
During an inspection of your firm located in Saint Gréoire, Franceon February 1, 2016, through February 4, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures bone staples, screws, plates, and intermedullary implants.  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.
 
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
 
We received a response, dated February 15, 2016, from Mr. Gilles Audic, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2). For example, your firm’s procedure “(b)(4) that your supplier have “(b)(4)” for products purchased (b)(4). However, your firm had no documentation available to show the following processes performed by your firm’s contract manufacturers were validated: (b)(4) 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm states that it will:
 
a.  (b)(4).
b.  (b)(4).
c.  (b)(4).
d.  (b)(4).
e.  (b)(4).
f.  (b)(4).
g.  (b)(4).
h.  (b)(4).
 
However, your firm did not evaluate the potential risk of nonconforming product being distributed, and actions required if nonconforming product was distributed.
 
2.    Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, your firm’s procedure, “(b)(4) does not include retesting and reevaluation of nonconforming product after rework, to ensure that the product meets its current approved specifications. Your firm documented (b)(4) supplier nonconformances for aspect, dimensional, labeling, and laser marking in 2014 and 2015, resulting in rework of (b)(4) products. However,there was no documentation of retesting and reevaluation of the (b)(4) products that were reworked.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm states:
 
a.  (b)(4).
b.  (b)(4).
c.  (b)(4).
d.  (b)(4).
e.  (b)(4).
f.  (b)(4).
g.  (b)(4).
 
However, your firm did not evaluate the potential risk of nonconforming product being distributed, and actions required if nonconforming product was distributed.
 
3.    Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40. For example, your firm’s SOP titled "Qualification et Validation des Process" (Process Validation, (b)(4)) has not been approved. The SOP is still maintained as a "draft" version.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated it would approve the draft validation procedure by the end of February, 2016; however, your firm did not state it would review its quality system procedures in use to determine if other procedures were still unapproved.
 
Our inspection also revealed that the Express Compressive Staple is 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 regarding 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. Significant deviations include, but are not limited to:
 
4.    Failure to report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
 
For example, on July 27, 2015, your firm became aware of an event described as the patient experiencing bone fracture as the surgeon tamped in an Express Staple during a Base wedge osteotomy procedure. It was documented that the patient had “poor bone quality,” leading to the fracture. There is no information in the complaint file that indicates what steps the surgeon took in follow up, but surgical intervention would be necessary to mitigate both the osteotomy and the new bone fracture. As such, this event meets the criteria of a reportable serious injury. Your firm did submit an MDR relating to this event (MDR 3010673777-2015-00001, received by FDA on September 23, 2015). However, this MDR was not submitted within the required 30 calendar day reporting timeframe.
 
We reviewed your firm’s response and conclude that it appears to be adequate. FDA verified that your firm was approved for production (b)(4) on May 26, 2016.
 
5.    Failure to adequately develop, implement and maintain written MDR procedures, as required by 21 CFR 803.17. For example, your firm’s MDR procedure “Medical Device Reporting & Vigilance,” (b)(4), Rev. A, dated February 24, 2015, lacks requirements for:
 
a.  Establishing internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits definitions of the terms “become aware,” “caused or contributed,” and “MDR reportable event,” from 21 CFR Part 803.3. 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).
 
b.  Establishing internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
 
i.  There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
ii.  There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
c.  Establishing internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed: the circumstances under which your firm must submit initial 30 days, supplemental or follow-up, and 5 day reports and the requirements for such reports.
 
d.  Describing how your firm will address documentation and record-keeping requirements, including:
 
i.  Documentation of adverse event related information maintained as MDR event files.
 
ii.  Information that was evaluated to determine if an event was reportable.
 
             iii.  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.
 
iv.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
The adequacy of your firm’s response dated February 15, 2016, cannot be determined at this time. Your firm’s response states that corrections are planned, yet your firm did not include documentation or evidence of the corrections. Without this documentation, FDA cannot make an assessment with respect to adequacy.
 
We recommend that your firm adjust its MDR procedure to include a process for identifying and evaluating events occurring outside the United States (U.S.) as potentially reportable to FDA. (b)(4), Rev. A, states on page 4 of 7 that this procedure (b)(4) for marketing in the U.S. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and evaluated for MDR decision making and submission to FDA as required by 21 CFR 803.50 and 21 CFR 803.53.
 
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
 
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.Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
 
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 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 thirty 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 Inspections Support Branch, White Oak Building 66, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to CMS case # 499206 when replying.  If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement at feb@fda.hhs.gov (email) or +1(240) 402-4020 (phone), or +1 (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/                                                                                   
Robin W. Newman
Office Director
Office of Compliance
Center for Devices and Radiological Health
 
 
Cc: U.S. Agent
      Novastep, Inc.
      Vadim Gurevich
      President/CEO     
      30 Ramland Road, Suite 200
      Orangeburg, NY 10962

Page Last Updated: 08/08/2016
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