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U.S. Department of Health and Human Services

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Enforcement Actions

Nidek Medical Products Inc 1/20/09

   

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

Public Health Service
Food and Drug Administration
 

New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217

Telephone: (615) 366-7801
FAX: (615) 366-7802

 

January 20, 2009

 

WARNING LETTER NO. 2009-NOL-04

 

FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED

Anand Chitlangia, President and CEO
Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, Alabama 35217

Dear Mr. Chitlangia:

During an inspection of your firm, located at 3949 Valley East Industrial Drive, Birmingham, Alabama, on September 23-26 and 30, 2008, an investigator from the United States Food and Drug Administration (FDA) determined your firm is a manufacturer, initial importer, repacker, relabeler, and specification developer of oxygen concentrators, nebulizers, and continuous positive airway pressure (CPAP) machines. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 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 are intended to affect the structure or function of the body. You may find the specific regulations through links in FDA's Internet home page at http://www.fda.gov.

This inspection revealed your devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:

1. Failure to evaluate complaints for determining whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a)(3).

Specifically, your firm routinely failed to document your evaluation of complaints to determine whether they represented MDR reportable events. Only one complaint out of the [(b)(4)] records reviewed during the inspection included a documented determination of whether or not the incident represented an MDR reportable event. For example, the following complaints were not evaluated to determine if they represented MDR reportable events:

a. Complaint Q [(b)(4)], date taken December 28, 2006, documents [(b)(4)] failed capacitors, in two different models of oxygen concentrators, and describes an incident where one capacitor started burning while the device was being used on a patient. The part was described as "burnt and cracked," and the patient complained of "smoke coming out" of the device.

b. Complaint Q [(b)(4)], date taken May 10, 2007, documents an overheated and melted motor run capacitor causing significant smoke and thermal damage to the Mark 5 Plus Oxygen Concentrator with serial number [(b)(4)]

c. Complaint Q [(b)(4)], date taken June 21, 2007, documents an incident in which a distributed oxygen concentrator burned due to the device being manufactured with an incorrect voltage module. Your firm sent a 115v module instead of a 220v module to the customer. When the customer attached the 115v module to the 220v module oxygen concentrator and applied power, the unit burned.

During the inspection, your firm's management agreed to modify your [(b)(4)] form to document complaints are being evaluated according to MDR regulation, as the form does not include an area designated to document this determination. Please provide a copy of your revised procedure and form with your response to this letter.

2. Failure to promptly review, evaluate, and investigate any complaint representing an event which must be reported to FDA under 21 CFR 803 - MDR, as required by 21 CFR 820.198(d).

For example, your firm failed to conduct adequate investigations of complaints Q [(b)(4)], Q [(b)(4)] and Q [(b)(4)], which represent MDR reportable events. See 21 CFR 803.50(a)(1) and (a)(2) deviations below. Your firm failed to document any investigation regarding these incidents. Further, during the inspection, your firm's management acknowledged no attempts were made to obtain any additional information regarding the specific details of these incidents.

Our inspection revealed your devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)]. Your firm failed or refused to furnish material or information regarding the device, as required by Section 519 of the Act, [21 USC 360i], and 21 CFR 803 - MDR. Significant deviations include, but are not limited to, the following:

1. Failure to submit an MDR to FDA within 30 days of receiving or otherwise becoming aware of information reasonably suggesting one of your commercially distributed devices may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

For example, complaint Q [(b)(4)], date taken December 27, 2007, documents a patient death and failure of a Mark 5 NUVO STD oxygen concentrator (serial number [(b)(4)] to alarm indicating inadequate or no flow of oxygen. Your firm determined, as described in the investigation section of the complaint, the alarm failed to function due to: poor part quality (re part number [(b)(4)], elbow fitting with metal clamp insert); and, low voltage of the battery controlling the alarm. The complaint documents your firm serviced the oxygen concentrator, which had no flow of oxygen at the output until the elbow fitting was replaced; and, your firm discontinued purchasing the elbow fitting from the supplier.

During the inspection, your firm management stated an MDR was not required for complaint Q [(b)(4)], because the device did not cause or contribute to the patient's death. Further, you stated: it is a life enhancing device, which provides supplemental oxygen rather than a device intended to be life sustaining; a cannula is used with the device rather than a mask; and, a patient using this device is breathing four-parts air and one-part oxygen coming out of the machine. This is inadequate, as you are required to submit an MDR when you become aware of any information reasonably suggesting your device may have caused or contributed to a death or serious injury, per 21 CFR 803.3. This means a death or serious injury was or may have been attributed to the medical device, or the device was or may have been a factor in a death or serious injury, including events occurring as a result of: failure; malfunction; improper or inadequate design; manufacture; labeling; or, user error.

Accordingly, your firm is required to submit an MDR for complaint Q [(b)(4)] because your device failed to alarm indicating inadequate or no flow of oxygen. Furthermore, complaint Q [(b)(4)] documents a patient death. The malfunction of the alarm due to a defective part and low voltage of the battery during occurrence of this event represents factors which may have caused or contributed to the death or serious injury.

2. Failure to submit MDRs to FDA within 30 days of receiving or otherwise becoming aware of information reasonably suggesting one of your commercially distributed devices malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:

a. Complaint Q [(b)(4)] date taken December 28, 2006, documents [(b)(4)] failed capacitors, in two different models of oxygen concentrators, and describes an incident where one capacitor started burning while the device was being used by a patient. The part was described as "burnt and cracked," and the patient complained of "smoke coming out" of the device.

b. Complaint Q [(b)(4)], date taken June 21, 2007, documents an incident in which a distributed oxygen concentrator burned due to the device being manufactured with an incorrect voltage module. Your firm sent a 115v module instead of a 220v module to the customer. When the customer attached the 115v module to the 220v module oxygen concentrator and applied power, the unit burned.

During the inspection, your firm's management stated the malfunctions would not likely cause or contribute to a death or serious injury, if they were to recur. This is inadequate as manufacturers are required to report malfunctions likely to cause or contribute to an MDR reportable event. The potential for a death or serious injury associated with the risk of fire in an oxygen-rich environment is documented and established, and considered to be a MDR reportable event involving a malfunction.

3. Failure to adequately conduct an investigation of each MDR reportable event and evaluate the cause of the event, as required by 21 CFR 803.50(b)(3).

For example, your firm failed to conduct adequate investigations of complaints Q [(b)(4)], Q [(b)(4)] and Q [(b)(4)], which represent MDR reportable events. See the 21 CFR 820.198(d) deviation above. Your firm failed to document any investigations regarding these incidents. Further, during the inspection, your firm's management acknowledged no attempts were made to obtain any additional information regarding specific details of these incidents, including patient diagnosis and status before or immediately after the device failure, or cause of death.

4. Failure to adequately develop, maintain, and implement written MDR procedures for internal systems to provide for timely and effective identification, communication, and evaluation of events subject to MDR requirements; as well as, a standardized review process or procedure for determining when an event meets the criteria for reporting, as required by 21 CFR 803.17.

For example, your firm's "Medical Device Report ing" procedure (SP [(b)(4)], Rev. [(b)(4)] Issue Date [(b)(4)] does not provide adequate procedures for timely and effective evaluation of events possibly subject to MDR requirements; nor, does it provide a standardized review process for determining when an event meets the criteria for reporting, e.g., determination of the seriousness of injuries. FDA notes your firm has no procedures or instructions for completing and submitting FDA MEDWATCH Form 3500A, report s of individual adverse events (See 21 CFR 803.11.).

Our inspection revealed your Mark 5 Oxygen Concentrators are adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)], because you do not have an approved application for premarket approval in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)], or an approved application for an investigational device exemption under Section 520(g) of the Act [21 USC 360j(g)]. Additionally, your devices are misbranded under Section 502(o) of the Act [21 USC 352(o)], as a notice or other information regarding changes or modifications made to the devices, which could significantly affect the safety or effectiveness of the devices was not provided to FDA, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(3)(i). Specifically, your modification to incorporate a [(b)(4)] in the Mark 5 Oxygen Concentrator requires a new suhmission per Section 510(k) of the Act [21 USC 360(k)], because a change in the [(b)(4)] can signific antly affect safety or effectiveness. The modification requires the settings to be tested and validated to demonstrate the [(b)(4)] to the patient accurately corresponds to the position of the [(b)(4)] on the [(b)(4)].

In addition, a review of our records indicates no premarket notification submissions per Section 510(k) of the Act [21 USC 360(k)] have been cleared for the Nuvo Q Oxygen Concentrators (models 500-003Q & 900-003Q), Nuvo QV Oxygen Concentrators (models 500-003QV & 900003QV), and Nuvo 8 Oxygen Concentrator (model 985). You must file a notice, per Section 510(k) of the Act [21 USC 360(k)], for any device at least 90 days before they are introduced into commercial distribution, as required by 21 CFR 807.81(a). Further, as you explained, during the inspection, about [(b)(4)] percent of your devices are shipped to foreign countries, please be advised all unapproved devices intended for export must comply with the requirements of Section 801(e) of the Act [21 USC 381(e)] or Section 802(b) of the Act [21 USC 382(b)]. These requirements include, but are not limited to, the devices must be properly labeled as "for export only" and are not sold or offered for sale in domestic commerce [See Section 801(e)(1) of the Act; 21 USC 381(e)(1)].

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 FDA 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 they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices to which the QS regulation deviations 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Rebecca A. Asente, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact Ms. Asente at (504) 219-8818, extension 104.

This letter is not intended to be an all-inclusive list of 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 Inspectional Observations, Form FDA 483, issued at the conclusion of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring your products into compliance.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District Office

 

 

Enclosure: Form FDA 483, dated September 30, 2008