Omron = Healthcare, Inc., Warning Letter

From: Subject: Omron Healthcare, Inc., Warning Letter Date: Mon, 3 Mar 2008 11:09:31 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0094_01C87D1F.0E195AE0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0094_01C87D1F.0E195AE0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6643c.htm Omron = Healthcare, Inc., Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	Chicago District 550 West Jackson Blvd., 15th Floor = Chicago,=20 Illinois 60661 Telephone: = 312-353-5863

January 18, 2008

WARNING LETTER
CHI-1-08

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Isao Ogino
President and CEO
Omron Healthcare, Inc. =
1200=20 Lakeside Drive
Bannockburn, IL 60015-1243

Dear Mr. Ogino:

During an inspection of your firm located in Bannockburn, Illinois, = conducted=20 from January 25 through February 16, 2007, an investigator from the = United=20 States Food and Drug Administration (FDA) determined that your firm is = an=20 initial importer and distributor of various diagnostic and therapeutic = foreign=20 manufactured medical devices.

Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the = Act)=20 [21 U.S.C. 321(h)], these products,are devices because they are intended = for use=20 in the diagnosis of disease or other conditions or in the cure, = mitigation,=20 treatment, or prevention of disease, or are intended to affect the = structure or=20 function of the body.

This inspection revealed, that these devices are adulterated within = the=20 meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the = methods=20 used in, or the facilities or controls used for, their manufacture, = packing,=20 storage, or installation are not in conformity with the Current Good=20 Manufacturing Practice (CGMP) requirements of the Quality System (QS) = regulation=20 found at Title 21, Code of Federal Regulations (CFR), = Part 820.=20 We received your response letters dated March 20, 2007, April 20, 2007, = and=20 November 6, 2007, concerning our investigator's observations noted on = the FDA=20 483, Inspectional Observations, that was issued to your firm. We address = these=20 responses below, in relation to each of the noted violations. These = violations=20 include; but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing = corrective=20 and preventive action that include requirements for analyzing = processes, work=20 operations, concessions, quality audit reports, quality records, = service=20 records, complaints, returned product, and other sources of quality = data to=20 identify existing and potential causes of nonconforming product, or = other=20 quality problems, as required by 21 CFR 820.100(a) and (a)(1).

For example, according to your Operational Procedures, Corrective = and=20 Preventive Action (CAPA), the Quality Manager will identify the=20 investigation plan to uncover the potential root cause of device = issues (any=20 written, electronic, or oral communications that allege deficiencies = related=20 to identity, quality, durability, reliability, safety, = effectiveness, or=20 performance).

-- An investigational pl an has not yet been identified for six = CAPAs=20 from 2005.

-- Nine other CAPAs have not yet been assigned for evaluation.=20

Your April 20, 2007 response to this observation appears to be = adequate=20 pending verification. Although your firm stated that all CAPAs = referenced were=20 appropriately assigned, you submitted no documentation showing that = this=20 action was completed.

CAPA # 34, requested 4/5/2005, described the HEM-907-CL19 Blood = Pressure=20 Monitors as having Units Malfunction and Inaccurate Readings. = Quality data=20 relating to CAPA #34 has not been adequately analyzed. For=20 example;

-- Only HEM-907 Blood Pressure Monitors received in = August=20 2004 were evaluated.

-- Lot numbers for model HEM-907-CL19 were never documented.=20

2. Failure to maintain a record of an investigation of a complaint = by a=20 formally designated unit that includes any corrective action taken, as = required by 21 CFR 820.198(e)(7).

For example, in ten of the thirteen complaints reviewed = concerning the=20 device model HEM-907-XL IntelliSence Digital Blood Pressure Monitor, = the=20 "Complaint Resolved By" field was annotated as "Pending Resolution," = although some repairs have been completed and your firm considers = the=20 complaints closed.

3. Failure to review, evaluate and investigate complaints involving = the=20 possible failure of a device, as required by 21 CFR 820.198(a) and = (c). (This=20 is a repeat observation from the last FDA inspection completed in July = 2003.)=20

For example, on 2/12/2007 a model HEM-705CPN was sent in for = repair. It=20 was switched out and a new one was sent out. There was no = investigation=20 done, however, to determine the cause of the failure.

Data was not forwarded to the foreign manufacturer so that it = could=20 investigate the cause of the failure.

4. Failure to include in your complaint investigation records the = devices'=20 control numbers and the nature and details of the complaints, as = required by=20 21 CFR 820.198(e)(3) and 21 CFR 820.198(e)(5), respectively.

For example, serial numbers were not entered for complaints = #123350 and=20 #55308.

Six of 13 complaint records reviewed did not contain documented=20 information on the nature and details on how the devices were=20 used.

Your November 6, 2007 response to this observation is not adequate = because=20 the new [redacted] third party complaint call center = will not=20 be operational until February 1, 2008.

5. Failure to adequately validate computer software used in an = automated=20 process for its intended use according to an established protocol, as = required=20 by 21 CFR 820.70(i).

For example, no person from your firm reviewed or approved the = third=20 party approval test results for the original = "[redacted]=20 Complaint System Validation" used in your firm's quality system.=20

Your November 6, 2007 response to this observation is not adequate = because=20 the new [redacted] third party complaint call center = will not=20 be operational until February 1, 2008. In addition, your response does = not=20 address plans for your firm to review and approve the third party = approval=20 test results for the [redacted] validation, which, = system=20 will replace the [redacted] Complaint System.

6. Failure to establish and maintain procedures for acceptance of = incoming=20 product, and to inspect, test, or otherwise verify incoming product as = conforming to specified requirements, as required by 21 CFR 820.80(b). =

For example, your firm's procedure entitled "Device Master = Record" is an=20 index of documentation required for procurement of materials and = components,=20 and evaluation of the devices. Your firm has not completed this form = for any=20 of the foreign manufactured devices initially distributed by your = firm.=20

Your April 20, 2007 response to this observation appears to be = adequate.=20 The document entitled "Verification of Purchased Products" appears to = address=20 this concern.

7. Failure of management with executive responsibility to appoint = and=20 document such appointment of, a member of management who, irrespective = of=20 other responsibilities, shall have established authority over and=20 responsibility for ensuring that quality system requirements are = effectively=20 established, as required by 21 CFR 820.20(b)(3).

For example, no one has been appointed as having this authority = since the=20 previous Quality Manager left your firm on 01/19/2007. =

8. Failure to establish and maintain procedures to ensure that all=20 purchased or otherwise received product and services conform to = specified=20 requirements, including quality. requirements that must be met by = suppliers,=20 contractors, and consultants, as required by 21 CFR 820.50(a).

For example, your firm has not identified for = [redacted]=20 (contract repair facility) the type of quality requirements that = must be=20 met.

9. Failure to establish and maintain procedures to control all = required=20 documents, as required by 21 CFR 820.40.

For example, in your firm's operational procedure entitled = "Control of=20 Documents," there is no explanation of the information that is to be = included in the "Document Status" field. That procedure does not = have the=20 required approving/releasing authority, the new effective date, and = the new=20 alphanumeric revision level document as required by your firm's = Operational=20 Procedure titled "CONTROL OF DOCUMENTS" (QOP-42-03, effective = 12/19/05,=20 revision A).

10. Failure to have documents established that meet the = requirements of 21=20 CFR 820.40(a). Documents must be available at all locations for which = they are=20 designated, used, or otherwise necessary, and to promptly remove all = obsolete=20 documents from all points of use.

For example, an obsolete version of the Quality System Manual = Index and=20 revision Status Revision C, effective 12/23/2005, was on your firm's = network. The current Revision F, effective 5/18/2006, includes a = list of=20 Inspectional Guidance Sheets (IGS) not = included in=20 the obsolete version and which was not available from your firm's = in-house=20 computer network.

The following obsolete documents were used by a repair technician = at=20 [redacted]

-- The Repair Department Work=20 Instruction entitled "Digital Blood Pressure Monitor Power-on Test," = document No. RDWI-018, Revision 3, issued 2/10/2005. New Repair = Department=20 Work Instruction document No. RDWI-018, Revision 3, originated on = 4/19/2005,=20 was not issued to the Repair Department.

-- The repair Department Work Instruction entitled "Calibration = Test and=20 Repair for Digital BPM," document No. RDWI-019, Revision 1, issued=20 2/10/2005. Instruction document No. RDWI-019, Revision 1, originated = on=20 4/19/2005, was not issued to the Repair Department.

-- The Repair Department Work Instruction entitled, "Check = Console For=20 SYS/DIA/PULSE/DEFLATION Rate" document No. RDWI-028, Revision 2, = issued=20 2/10/2005. Document No. RDWI-028, Revision 2, originated on = 4/20/2005, was=20 not issued to the Repair Department.

-- The Repair Department Work Instruction entitled, "Test Cuff - = Digital=20 BPM," document No. RDWI-033, Revision 1, issued 6/21/1997. Document = No.=20 RDWI-033, Revision 2, originated on 2/10/2005, was not issued to the = Repair=20 Department.

11. Failure to have approved changes communicated to the = appropriate=20 personnel in a timely manner, as required by 21 CFR 820.40(b).

For example, revisions to the following lists of "Repair = Department Work=20 Instructions" were approved by the Quality Manager, but the Repair=20 Supervisor was unaware of them:

-- RDWI-018 issued 4/19/2005 Revision 3

-- RDWI-019 issued 4/19/2005 Revision 1

-- RDWI-028 issued 4/20/2005 Revision 2

-- RDWI-033 issued 4/20/2005 Revision 2 =

Our inspection also revealed that your firm's MC-600 Thermometer and = Omron=20 HEM-630 Blood Pressure Monitor devices are misbranded under Section = 502(t)(2) of=20 the Act, 21 U.S.C. 352(t)(2), in that your firm failed to or refused to = furnish=20 material or information respecting the devices that is required by or = under=20 Section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - the = Medical Device=20 Reporting (MDR) regulation. Significant deviations include, but are not = limited=20 to, the following:

1. Failure to submit a report to FDA, and a copy of this report to = the=20 manufacturer, as soon as is practicable but no later than 30 calendar = days=20 after the day that your firm receives or otherwise becomes aware of=20 information from any source, including user facilities, individuals, = or=20 medical or scientific literature, whether published or unpublished, = that=20 reasonably suggests that one of your marketed devices may have caused = or=20 contributed to a death or serious injury, as required by CFR 21 = 803.40(a).=20

For example, on 8/15/2005, your firm was made aware of an event = that=20 alleged that an MC-600 thermometer had caused a burn on an eight = month old=20 baby girl's underarm. Your firm did not send a FDA Form 3500A for = this event=20 to FDA until 9/29/2005.

2. Failure to include complete information in the above report, if = the=20 information is known or should be known to you, as described in 21 CFR = 803.40,=20 containing the information required by 21 CFR 803.42 (which = corresponds=20 generally to the format of FDA Form 3500A).

For example, Section F of the FDA Form 3500A was incomplete = (numbers=20 2-14) and did not state whether a copy of the report had been sent = to the=20 manufacturer.

Sections G and H of the FDA Form 3500A were incorrectly = completed,=20 implying that your firm was the manufacturer of the MC-600 = thermometer=20

Your April 20, 2007 response to these observations appears to be = adequate.=20

3. Failure to submit a report to the manufacturer as soon as = practicable,=20 but no later than 30 calendar days after the day that your firm = receives or=20 otherwise becomes aware of information from any source, including user = facilities, individuals, or through your firm's own research, testing, = evaluation, servicing, or maintenance of one of your firm's devices, = that=20 reasonably suggests that one of your firm's devices has malfunctioned, = and=20 that this device or similar device that your firm markets would be = likely to=20 cause or contribute to a death or serious injury if the malfunction = were to=20 recur, as required by 21 CFR 803.40(b).

For example, the following two voluntary Medwatch Reports were = received=20 by FDA and forwarded to your firm. There is no documented evidence = that your=20 firm reviewed these reports for MDR reportability and your firm = never sent=20 these reports to the corresponding foreign manufacturer through an = FDA Form=20 3500A within the 30 calendar days.

-- MedWatch report dated 3/22/2004, regarding model HEM-630, a = digital=20 wrist blood pressure monitor. When this, digital wrist blood = pressure.=20 monitor was compared to a standard arm cuff, it was consistently 15 = and 20=20 mm higher than the standard cuff. This device deficiency was never = reported=20 to the foreign manufacturing firm.

-- MedWatch report dated 09/04/2001, regarding model HEM-630, a = digital=20 wrist blood pressure monitor. The reading from that monitor was = moderately=20 elevated when used to monitor a patient's blood pressure in his home = and=20 office. When the readings were later compared to several different=20 instruments used in his office and the office of his internist, the = digital=20 wrist monitor instrument consistently gave a higher reading with the = magnitude of the differences varying considerably. In addition, we = have no=20 information showing that your firm reviewed the above referenced = MedWatch=20 reports to determine whether you should submit them to the = manufacturer.=20

We have reviewed your April 20, 2007, response and have concluded = that it is=20 not adequate because your firm's draft revised MDR procedures are not = complete=20 and have not been implemented, and your firm has not completed training = on the=20 procedures.

4. Failure to develop, maintain, and implement complete written = medical=20 device reporting (MDR) procedures, as required by 21 CFR 803.17.

For example, your QMS Operational Procedure QOP-85-05 entitled = "Medical=20 Device Reporting (MDR)," does not address the handling of = information you=20 become aware of whereby a device has malfunctioned and if such = device or=20 similar device marketed by the manufacturer or distributor would be = likely=20 to cause or contribute to a-death or serious injury, if the = malfunction were=20 to recur.

We have reviewed your April 20, 2007 response and have concluded = that it is=20 not adequate because your firm's draft revised MDR procedures are not = complete=20 and they have not been implemented, and your firm has not completed = training=20 on the procedures. In reviewing these procedures, however, we noted = the=20 following:

Page 3 of 6, item 3.3.2, the definition of a reportable = malfunction=20 should be inserted at the top of the list of Reportable Malfunction, = i.e.,=20 the requirement in 21 CFR 803.40(b).

Page 4 of 6, item 3.3.4, 3rd bullet, "health care professional" = language=20 should be replaced with the language in the regulation; refer to 21 = CFR=20 803.20(c)(2). This language includes "physicians, nurses, risk = managers, and=20 biomedical engineers" and is, therefore, not limited to health care=20 professionals.

Page 4 of 6, items 3.4 and 3.5, MedWatch Form 3500 needs to be = changed to=20 3500"A" in both items.

Please note that page 2 of 6, items 2.1 - 2.2, of your firm's draft = revised=20 MDR procedures, "10 working days" could be changed to "30 calendar = days" to=20 comply with 21 CFR 803.40(a).

Please note that, once finalized, written MDR procedures cannot be = verified=20 until the next inspection, since the regulation requires that you = "develop,=20 maintain, and implement"the procedures.

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in = regulatory=20 action being initiated by the Food and Drug Administration without = further=20 notice. These actions include, but are not limited to, seizure, = injunction,=20 and/or civil money penalties. Also, federal agencies are advised of the = issuance=20 of all Warning Letters about devices so that they may take this = information into=20 account when considering the award of contracts. Additionally, premarket = approval applications for Class III devices to which the Quality System=20 regulation deviations are reasonably related will not be approved until = the=20 violations have been corrected. Requests for Certificates to Foreign = Governments=20 will not be granted until the violations related to the subject devices = have=20 been corrected.

Please notify this office in writing within 15 working days from the = date you=20 receive this letter of the specific steps you have taken to correct the = noted=20 violations, including an explanation of how you plan to prevent these=20 violations, or similar violations, from occurring again. Include = documentation=20 of the corrective action you have taken. If your planned corrections = will occur=20 over time, please include a,timetable for implementation of those = corrections.=20 If corrective action cannot be completed within 15 working days, state = the=20 reason for the delay and the time within which the corrections will be=20 completed.

Finally, you should know that this letter, is not intended to be an=20 all-inclusive list of the violation(s) at your facility. It is your=20 responsibility to ensure compliance with applicable laws and regulations = administered by FDA. The specific violation(s) noted in this letter and = in the=20 Inspectional Observations, Form FDA 483 (FDA 483), issued at the = closeout of the=20 inspection may be symptomatic of serious problems in your firm's = manufacturing=20 and quality assurance systems. You should investigate and determine. the = causes=20 of the violation(s), and take prompt actions to correct the violation(s) = and to=20 bring your products into compliance.

Please note that the November 2, 2004 letter your firm submitted for = Recall #=20 Z-0382-05 (Medication Bottle for NE-U22 Nebulizer) appears to have = followed the=20 reporting guidelines in 21 CFR Part 7, Subpart B (Recalls). Since this = recall=20 was classified Class II, your firm should have also submitted a Removal = Report=20 (21 CFR Part 806). The information your firm submitted, including = additional=20 information submitted in a November 8, 2004, letter, did not include a = Removal=20 Report number and the device's expected life [21 CFR 806.10(c)(1) and = (c)(10)].=20

Please also note that the October 13, 2005 letter your firm submitted = for=20 Recall # Z-0466-06 (3-way Instant Thermometer) appears to have also = followed the=20 reporting guidelines in 21 CFR Part 7, Subpart B. This recall was = classified=20 Class II. While your firm later submitted a Removal Report number, your = firm did=20 not submit the marketing status of the device, the device listing = number, a=20 related Medical Device Reporting (MDR) number, and the device's expected = life=20 [21 CFR 806.10(c)(4), (8) and (10)].

Please be aware that your firm is required to submit for Class I and = II=20 recalls a Corrections and Removal report under 21 CFR 806.10(b) within = 10=20 working days of initiating such correction or removal, and that the = report must=20 contain the items listed in 21 CFR 806.10(c). If the required = information is not=20 immediately available, your firm must provide a statement as to why the=20 missing/incomplete information is not available and state when the=20 missing/incomplete information will be submitted to the appropriate FDA = District=20 Office [CFR 806.10(c)(13)].

In addition, if your firm decides that a correction/removal is not = subject to=20 reporting under 21 CFR 806.10, your firm is required to comply with the=20 provisions of 21 CFR 806.20(a), and (b).

Your response to this letter should be sent to Matthew J. Sienko, = Compliance=20 Officer, at the above address. If you have any questions about the = content of=20 this letter please contact Mr. Sienko at (312) 596-4213.

Sincerely,

/S/

Scott J. MacIntire
District Director

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FDA/Freedom=20 of Information

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