- MWT Materials, Inc.
- Issuing Office:
- New Jersey District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969
August 06, 2015
VIA UNITED PARCEL SERVICE
Mr.Michael M. Katz
MWT Materials, Inc.
90 Dayton Avenue
Suite 6E, Building 21
Passaic, New Jersey 07055 15-NWJ-06
Dear Mr. Katz:
During an inspection of your firm located in Passaic, New Jersey on April 22, 2015 through April 28, 2015 investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures radio frequency shielding Accusorb MRI devices, such as blankets and body-part shielding covers, for use during Magnetic Resonance Imaging (MRI). 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 any 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 your written response, dated April 30, 2015, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, that was issued to your firm. We address your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, pursuant to 21 CFR 820.198(a). For example, your firm has not established procedures for complaint handling.
We reviewed your response and conclude that it is not adequate. Your response did not provide any complaint handling procedures. The procedures should minimally include requirements to ensure that all complaints are processed in a timely manner; that oral complaints are documented upon receipt; and that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting.
2. Failure to establish a design history file, pursuant to 21 CFR 820.30(j). For example, your firm has not established design history file(s) for Accusorb MRI devices.
We reviewed your response and conclude that it is not adequate. Your response did not provide design history files (DHF) for each of the devices that you manufacture. Your DHF shall contain or reference the records necessary to demonstrate that the devices were developed in accordance with the approved design plan and the requirements of this part. Additionally, you stated to our investigators that you have not documented design changes for your devices within the past six years. Design changes should be documented in the DHF or referenced in relation to the location of associated records.
3. Failure to adequately maintain adevice master record (DMR), pursuant to 21 CFR 820.181. For example, your firm has not maintained a complete DMR which includes, or refers to the location of, device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications for each type of device that you manufacture.
We reviewed your response and conclude that it is not adequate. Your response did not provide a complete DMR for each of your devices. Each manufactureris required to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, Document Controls.
Our inspection revealed that the Accusorb MRI devicesare also 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:
4. Failure to develop written medical device reporting (MDR) procedures, pursuant to 21 CFR 803.17. For example, your firm has not developed, maintained, or implemented written MDR procedures to ensure that death and serious injury reports are reported to the Agency within required timeframes and adequately investigated.
We reviewed your response and conclude that it is not adequate. Your response did not provide MDR procedures which provide for an internal system for timely and effective identification, communication,and evaluation of events that may be subject to MDR requirements. The procedures shall also provide for a standardized review process or procedure for determining when an event meets the criteria for reporting and timely transmission of complete medical device reports to the FDA.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or
to schedule further communications, you may contact
the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Our inspection also revealed that your firm's Class II devices for radio frequency shielding/absorbing blankets and body-part shielding covers for application in the MRI environment 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 806 - Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
5. Failure to report to the FDA within ten (10) days, a correction or removal, conducted to reduce a risk to health posed by a device, pursuant to 21 CFR 806.10(a)(1). For example, your firm issued a document, dated October 6, 2014, which advised users of significant changes to Safety and Use Instructions for Accusorb MRI products. These changes included, but were not limited to, changing the requirement of 1cm of space between the patient and the MRI (black) side of the Accusorb MRI blanket to 2 cm. You did not make the Agency aware of the field correction that was issued.
We reviewed your firm's response and conclude that it appears to be adequate. Your firm has contacted the local FDA district office to report the correction or removal, and the district office has confirmed receipt of your recall information.
Our inspection also revealed that
your Accusorb MRI devices, including radio frequency shielding/absorbing blankets and body-part
shielding covers for application
in the MRI environment, are adulterated under
section 501(f)(1)(B) of the
Act, 21 U.S.C.
because your firm does not have an approved
application for premarket approval
(PMA) in effect pursuant to section 515(a) of the Act, 21
360e(a), or an approved application for
an investigational device exemption under
section 520(g) of the Act,
The device is also misbranded under section
502(o) of the Act, 21
U.S.C. § 352(o)
, because your firm did not notify the
agency of its intent to introduce the device into commercial distribution, as required by
(k) of the Act
, 21 U.S.C. § 360(k). For
a device requiring premarket
approval, the notification required by
section 510(k) is
deemed satisfied when a PMA is pending before the agency. [21
The kind of information that your firm needs to
submitin order to
obtain approval or clearance for the device
is described on the
Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.
The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Your response states that you will not sell or market these products until your 510(k) has been cleared, however, your response does not address how the devices already on the market will be rectified or state when you plan on submitting the 510(k).
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2015.
Therefore all of your firm's devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices we remanufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. §360(j)).
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies maybe 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 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 devices 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, as well as 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 fifteen business days, state there as on for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to the Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054. Refer to the Unique Identification Number (CMS case #469826) when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Stephanie Durso at 1-973-331-4911.
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.
New Jersey District