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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nexera Medical, Inc. 10/16/12

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
           FAX: 407-475-4770
 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
FLA-13-03
October 16, 2012
 
Paul M. Sallarulo
Chief Executive Officer
Nexera Medical, Inc.
3343 W. Commercial Blvd., Suite 103
Fort Lauderdale, FL 33309 U.S.A.
 
DearMr. Sallarulo:
 
During an inspection of your firm located in Fort Lauderdale, Florida on July 30, 2012, through July 31, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SpectraShield™ 9500 Surgical N95 Respirator. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
 
This inspection revealed that this device is 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, its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  We received a written response from you dated August 20, 2012, 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 the noted violations.
 
Violations 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 procedure, Product Design and Development, Document #ENG108, Rev. 0.0, does not include provisions for the conduct of design validation. Your firm has not conducted and documented design validation for the SpectraShield™ 9500 Surgical N95 Respirator, including the documentation of the conduct of risk analysis, as specified in your procedure, Document #ENG108.
 
We have reviewed your response and have concluded that it is inadequate.  Although you provided a device drawing, a drawings and schematics procedure (Document #ENG101, Rev. 0.1), and your November 2007 Long-Term Respirator Wear and Integrity Study, these documents do not provide for the requirements of design validation specified in 21 CFR 820.30(g). Further, your response does not include any specific plan or provide evidence of immediate corrections and systemic corrective actions.
 
2.      Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a) and their results, as required by 21 CFR 820.100(b).
 
For example: You do not have Corrective and Preventive Action (CAPA) procedures. In addition, you failed to document any investigations and effectiveness checks and other activities required for CAPAs for the corrections implemented by your firm as a result the Warning Letter dated May 11, 2009, you received from FDA.
 
We have reviewed your response and have concluded that it is inadequate.  We acknowledge receipt of procedure, Customer Service Contact / Complaint Handling, Document #CAPA 102, Rev. 0.1. This procedure does not define the process for identifying and elevating corrective actions associated with nonconformities to CAPAs. Further, your response does not include any specific plan or provide evidence of immediate corrections and systemic corrective actions.
 
3.      Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
 
For example: Your procedure, Vendor Selection, Files, and Inspections, Document #SPI106, Rev. 0.0, requires an on-site inspection of vendors of "...critical components, or for Purchases where Nexera relies on the vendor's Quality Assurance to reduce receiving inspection/testing..." Your firm has not conducted and documented on-site inspections of your current and former contract manufacturers of the SpectraShield™ 9500 Surgical N95 Respirator device and your supplier of FOSSHIELD antimicrobial fabric, used in the manufacture of the respirator device, as specified by your procedure, Document #SPI106. Further, you do not maintain a SPI106-3 – VENDOR SURVEY FORM for your fabric supplier and the contract manufacturers of the SpectraShield™ 9500 Surgical N95 Respirator, also required by your procedure, Document #SPI106.
 
We have reviewed your response and have concluded that it is inadequate because you have not established or implemented a procedure to ensure that all contracted services and purchased products conform to specified requirements. As part of your response, you provide ISO certification and processing procedures for your supplier of FOSSHIELD antimicrobial fabric. However, your response fails to demonstrate you have implemented your revised procedure, SPI106, Vendor Selection, Files, and Inspections, Rev. 0.1, Section 2.1, for this critical component supplier, to conduct an on-site inspection.
 
4.      Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
 
For example: You do not have quality audit procedures and do not conduct quality audits.
 
We have reviewed your response and have concluded that it is inadequate. We acknowledge the provided procedure, Internal Audit Guideline, Document #CAPA 107, Rev. 0.1. However, this procedure is not signed and dated as approved and implemented for use. Further, you have not conducted and documented any internal quality audits.
 
Our inspection also revealed that your device 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 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. 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’s representative stated your firm has no MDR procedures.
 
We have reviewed your response and have concluded that it is inadequate. We acknowledge your August 20, 2012 response includes the newly created procedure, Medical Device Reporting, Document #CAPA 102 MDR, Rev. 0.0. However, your firm's procedure fails to meet the requirements of 21 CFR 803.17.  Review of your firm's newly created MDR procedure noted the following issues, to include but not limited to:
 
1.      Your firm’s procedure fails to establish a process that provides for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
 
a.       Not all definitions are provided for what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions, based on 21 CFR 803.3, of the term "become aware" and definitions of the terms "reasonably known" and "reasonably suggests," found in 21 CFR 803.50(b) and 803.20(c)(1), respectively.
 
b.      There is not a definition of an MDR-reportable event that is consistent with the definition as listed in 21 CFR 803.3.
 
2.      Your firm's procedure does not include a process for identifying and evaluating events occurring outside the U.S. as potentially reportable to FDA, as required by 21 CFR 803.50 and 21 CFR 803.53. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that has been cleared or approved in the U.S. and is also marketed in a foreign country. 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.
 
3.      Your firm's procedure does not establish internal systems that provide for timely submission of complete medical device reports. Specifically, the following are not addressed:
 
a.       The procedure does not include the address for where to submit MDR reports:
By standard mail:
 
MDR Mandatory Reporting
U.S. Food and Drug Administration
Center for Devices and Radiological Health
P.O. Box 3002
Rockville, MD 20847-3002
 
If sent by Fedex or other courier services:
 
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
16071 Industrial Drive, Room 258
Gaithersburg, Maryland 20877-1462
 
b.      There are no instructions for completion of the MedWatch 3500A form, nor are there instructions on how to access the MedWatch 3500A form.
 
c.       The procedure does not reference timeframes in which the firm must submit initial MDR reports to the FDA, nor does the procedure stipulate calendar or work days, as specified in 21 CFR 803.50 and 21 CFR 803.53.
 
You should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice.  These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.  Also, 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.  Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.  Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject device have been corrected.
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions you have taken.  If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities.  If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this letter.
 
Your response should be sent to:
 
Salvatore N. Randazzo, Compliance Officer
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida, 32751 
 
If you have any questions about the content of this letter please contact: Salvatore N. Randazzo at (407) 475-4712.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. 
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District