| Public Health Service Food and Drug Administration |
Waterview Corporate Center Telephone (973) 331-4906 |
Department of Health and Human Services
September 30, 2010
WARNING LETTER
VIA UPS EXPRESS
AND FACSIMILE
10-NWJ-18
Leslie H. Sherman
President
Impact Instrumentation, Inc.
27 Fairfield Place
West Caldwell, NJ 07006
Dear Mr. Sherman:
During an inspection of your firm located in West Caldwell, New Jersey on February 17, 2010 through March 8, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Uni-Vent® 731 Series Model EMV, Uni-Vent® 731 Series Model EMV+ (800-EMVP-01), 754 Uni-Vent Eagle Portable Ventilator, and the Special Medical Emergency Evacuation Device (SMEED). 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 are intended to affect the structure or function of the body.
This inspection revealed that you have not obtained marketing approval or clearance before you began offering the Uni-Vent® 731 Series Model EMV+ (800-EMVP-01) for sale, which is a violation of the law. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to
be both safe and effective or substantially equivalent to other devices already legally marketed.
Specifically, the Uni-Vent® 731 Series Model EMV+ (800-EMVP-01) is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
The Uni-Vent® 731 Series Model EMV+ (800-EMVP-01) contains the following changes or modifications that were not included for the Uni-Vent® 731 Series Model EMV+ (800-EMVP-00) under 510(k) number K091238: 1) the addition of the "Pleth" waveform feature; 2) Volume Targeted Synchronized Intermittent Mandatory Ventilation (SIMV) mode; 3) Pressure Targeted SIMV mode; 4) Continuous Positive Airway Pressure (CPAP) mode; Pressure Support operating mode; and 5) an apnea alarm. These added modes and features represent significant changes or modifications in design, components, method of manufacture, or intended use that could significantly affect the safety or effectiveness of the device and represent a major change or modification in the intended use of the device. Therefore, these changes or modifications require the submission of a new 510(k). 21 C.F.R. 807.81(a)(3). For example,
1. The addition of the "Pleth" waveform feature could significantly affect the safety or effectiveness of the device as it acts as a basis on which to provide medical intervention.
2. The device is cleared to provide full ventilatory support. The addition of the Volume Targeted SIMV, Pressure Targeted SIMV, Pressure Targeted SIMV, Continuous Positive Airway Pressure, and Pressure Support, and Pressure Support modes of ventilation could significantly affect the safety or effectiveness of the device as they provide both full and partial ventilatory support.
3. The addition of the apnea alarm could significantly affect the safety or effectiveness of the device as device safety would purportedly increase.
Additionally, a new 510(k) clearance is required for changes in labeling, namely the Operator's Manual, Impact Part Number 906-EMVP-01 to incorporate the differences cited, and the Model & Serial Number Label, to differentiate between 800-EMVP-01 and 800-EMVP-00.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81 (b). The kind of information you need to
submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
This inspection also revealed that the Uni-Vent® 731 Series Model EMV, UniVent ® 731 Series Model EMV+ (800-EMVP-00), Uni-Vent® 731 Series Model EMV+ (800-EMVP-01), and 754 Uni-Vent Eagle Portable Ventilator, 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response from Alan Giordano, Regulatory Affairs Manager, dated March 23, 2010, 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 each of the noted violations.
These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 C.F.R. 820.100(a). For example:
a. Your firm's Corrective and Preventive Action procedure, QAP/0600, Rev. F, dated August 15, 2005, failed to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1).
b. Your firm received complaints during the month of October, 2009 for the 754 Uni-Vent Eagle Portable Ventilators (Complaint/Serial # PC09-122/0604188, PC09-123/0504010, and PC09-135/9709011) concerning compressor motors failing to operate, ventilator displaying a code 2 alarm, and a ventilator providing a low tidal volume. As a result, your firm determined that the compressors were having intermittent output issues and performed repairs for the units returned from your customers. There was no further investigation on the root causes of the intermittent output issues, as required by 21 CFR 820.100(a)(2). Additionally, your firm failed to perform corrective and preventive actions as required in section 5 of your Complaint Resolution and Close Out form (QAP/0500-6, Rev.B) in order to prevent recurrence of nonconforming product in distribution, and those not yet distributed by your firm. Thus, your firm failed to maintain procedures for identifying the actions needed to correct and prevent recurrence of nonconforming product, as required by 21 CFR 820.100(a)(3).
c. Your firm received complaints from September 15,2008 through June 29, 2009 concerning defective transducers (b)(4) of returned 754 Uni-Vent Eagle Portable Ventilators causing insufficient tidal volumes and failure of device to operate. No corrective and preventive actions were performed for three of the complaints (Complaint/Serial # PC09-090/0711052, PC09-077/0708133, and PC09-013/9901024) received by your firm in order to prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
d. Your firm received complaints from June 25, 2009 through November 20, 2009 concerning defective battery packs (disconnection of battery terminal wires at the battery pack) and a vacuum gauge out of specification for returned 305 series Portable Aspirators causing failure of the aspirator to operate or failure to operate in high mode. Two of the complaints (Complaint/Serial # PC09-140/9905011 and PC09-089/ 8501107) documented that the aspirators were repaired by your firm and were later (b)(4) sent back to your firm for the same nonconforming issue. No corrective and preventive actions were performed for four of the complaints (Complaint/Serial # PC09-140/9905011, PC09-139/9605047, PC09-089/8501107, and 9404063/PC09-058) received by your firm as required by your Complaint Resolution and Close Out form. Your firm failed to prevent recurrence of nonconforming product in distribution, as required by 21 CFR 820.100(a)(3).
The adequacy of your firm's response dated March 23, 2010 cannot be determined at this time. Your firm did not submit documentation which includes a description and evidence of implementation of the correction, corrective action, and proposed preventive action. The response states that the procedures will be modified; however, no copies of the revised procedures were included. Additionally, the response does not address why corrective and preventive actions are not performed for complaints received for nonconforming product.
2. Failure to adequately review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 C.F.R. 820.198(c).
Specifically, your firm's QAP/0500 Complaint Handling, Rev. K, October 9, 2008, does not require that any complaint involving the possible failure of a device to meet any of its specifications be investigated. For example, there was a lack of investigation into the following released, returned, and failed devices:
a. Complaint No. PC09-090 and Service Malfunction Record No. 090628 indicate that 754 Uni-Vent Eagle Portable Ventilator, Serial No. 0711052, had a defective transducer and was found not having any oxygen Tidal Volume and Fraction of Inspired Oxygen (FIO2) readings during service.
b. Complaint No. PC09-135 and Service Malfunction Record No. 09V1159 indicate that 754 Uni-Vent Eagle Portable Ventilator, Serial No. 9709011, had a failed compressor motor, provided low Tidal Volume, and was found having an intermittent CPU Printed Circuit Board and not having any oxygen and external air Tidal Volume and FIO2 readings during service.
c. Complaint No. PC09-140 and Service Malfunction Record No. 09A245 indicate that 305GR Portable Aspirator, Serial No. 9905011, failed to operate due to a disconnection of a battery terminal wire. The problem occurred three days after the customer received the product that was sent previously for the same problem.
The adequacy of your firm's response dated March 23, 2010 cannot be determined at this time. Your firm did not submit documentation which includes a description and evidence of implementation of the correction, corrective action, and proposed preventive action. The response states that the procedures will be modified; however, no copy of the revised procedure was included.
3. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the device history record (DHR), as required by 21 C.F.R. 820.90(b)(2).
For example, your firm initiated a change request order "QAP/0101-1, Rev. F, dated May 11, 2009" for your Uni-Vent® 731 Series Model EMV to alleviate a high O2 pressure leak. The change performed by your firm indicates a drawing note change that specifies (b)(4)
Your firm did not document any justification for product release until after the FDA investigator observed this deficiency during the inspection noted on Hardware Change Sheet, Rev. 3.0, dated February 23, 2010. Your firm released units with the high pressure leak nonconformities prior to determining if there were any possible adverse effects that could occur from the changes that were made to the devices.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 C.F.R. 820.90(a), and failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 C.F.R. 820.90(b)(1). For example:
a. QCP/0100 Control of Nonconformities, Rev. J, dated October 4, 2007, does not ensure that the evaluation of the nonconformance includes a determination of the need for an investigation. Additionally, the procedure does not require the documentation of justification for use of nonconforming product including the signature of the individual(s) authorizing the use.
b. Your firm had 28 Nonconforming Material Record Sheets (NCMs) for a peep leak test failure (workmanship issue for a loose zip tie on the flow manifold or another assembly) for the Model 754 ventilators. No documented investigation was conducted until after the FDA investigator observed the deficiency during the inspection.
5. Failure to adequately establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 C.F.R. 820.30(d). For example, your firm did not ensure that those design outputs that are essential for the proper functioning of the Uni-Vent® 731 Series Model EMV+ device are identified.
Your firm's response dated March 23, 2010 is not adequate because your firm did not submit documentation which includes evidence of implementation of the correction, corrective action, and proposed preventive action. The response states that the design output procedure will be modified to identify the assemblies which are subjected to further testing, without providing accompanying evidence.
6. Failure to establish and maintain procedures for the validation, or where appropriate verification, of design changes before their implementation, as required by 21 C.F.R. 820.30(i). For example, your firm's DES/0700 Design Change, Rev. E, December 1, 2005 does not ensure that validation, or where appropriate verification, be performed of design changes before they are implemented.
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 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 fifteen (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 occurring again. Include documentation of the corrective action 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: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei via telephone at 973-331-4906 or via fax at 973-331-4969.
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 Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout 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 to bring your products into compliance.
Sincerely yours,
/S/
Diana Amador-Toro
District Director
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