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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ohio Medical Corporation 7/22/09


hhsbluebirdDepartment of Health and Human Services

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


July 22, 2009




Mr. David Finney
President and Chief Executive Officer
Ohio Medical Corporation
1111 Lakeside Drive
Gurnee, IL 60031

Dear Mr. Finney:

United States Food and Drug Administration (FDA) investigators conducted an inspection of your firm located in Gurnee, IL, from May II through May 19,2009. The investigators determined that your firm manufactures portable suction units, oxygen flow meters and vacuum regulators. 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 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 (cGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Mr. David Finney, President and Chief Executive Officer, dated June 16,2009, concerning our investigators' observations noted on the Form FDA 483, Inspectional Observations, which was issued to Mr. Finney. 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, including identifying the action(s) needed to correct and prevent reoccurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example:

a. Seven complaints (011249, 011599, 011600, 011706, 011726, 011763, and 012007) were received between 10/15/08 and 2/19/09 that were verified to be caused by intermittent timing not meeting specifications for the Push to Set/Intermittent Suction Units (PTS ISU). Two of these complaints (011249 and 011763) were found to be Out of Box failures for the timing drift problem. In addition, review of device history records revealed a high level of nonconformances for the timing module component and high process variability for the timing setting. Specifically, Lots ISU097006, ISU097008, and ISU097012 had 9 nonconformances, 19 nonconformances, and 22 nonconformances, respectively for the timing module component, and the mean "On" and "Off' times calculated for Lots ISU097013, ISU097014, and ISU097015 (which cover 600 total devices) were found to be below the target with percent relative standard deviation values ranging from (b)(4) to (b)(4). No CAPA has been initiated to investigate the verified complaints, determine a root cause and make a corrective action.

b. Three complaints (011740, 012234, and 012168) were received between 1/16/09 and 3/26/09 describing cracking of plastic vacuum collection bottles. The supplier of the bottles was found to have changed from (b) (4) material to (b) (4); however, incoming inspection of the bottles did not identify this material change. A reference on the plastic properties of (b) (4) advise not to use (b) (4) that is autoclaved in a vacuum system because the autoclave process can weaken the plastic. The vacuum collection bottles are used to collect biological waste from suction procedures and as such would be subject to autoclaving in healthcare settings. No CAPA had been initiated at the start of the inspection. CAPA 09-03 was opened on 5/13/09 to evaluate the risk associated with the use of the cracking bottles; however, the CAPA does not include an evaluation of why the material change was not identified during incoming inspection.

Your response, dated June 16, 2009, did not provide documents to support the proposed corrective actions. For example, details regarding the (1) implementation and monitoring of a supplier corrective action request program, (2) revisions to the CAPA procedure, and (3) findings of CAPA 09-04, would need to be verified during a follow-up inspection. In addition, the response does not address any corrective action to the incoming specification for the vacuum collection bottles to verify coloring or composition upon receipt. The corrective action is inadequate in that it lacks enough detail to ensure that the corrective actions will be complete.

2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, including documenting the evaluation and investigation of any nonconformance, as required by 21 CFR 820.90(a). For example:

a. Nonconformance reports 090213-125946N and 090213-090309N involved damaged valve plates for timing modules of PTS ISU devices. The valve plates were used despite being described as "damaged" in the nonconformance reports. There is no documented evaluation of the decision to use the nonconforming parts by the head of QA or by a Material Review Board.

b. Nonconformance reports 090225-151922N and 090213-083143N could not be located. Nonconformance 0902l3-083l43N is described in the summary table of non-conformances as a damaged timing plate that the engineer said to use anyway.

c. Nonconformances are combined and initiated as a single nonconformance over unspecified periods of time. Specifically, during the manufacture of PTS lSU, Lot lSU097006, 9 timing module assemblies had to be replaced because the units failed during production testing. Lot lSU097006 was manufactured between 1/28/09 and 2/4/09; however, there is no nonconformance entry for the timing module assembly on these dates. The only entry for timing module assemblies in the nonconformance log was entered in April 2009 for 716 nonconforming timing module assemblies over an unspecified period of time. There has not been a documented investigation of timing module nonconformance.

Your response, dated June 16,2009, addressing nonconforming material procedures, appears to be adequate. We will evaluate adequacy of the corrective actions during our next FDA inspection of your facility.

3. Failure to maintain complaint files, including the establishment and maintenance of procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that all complaints are processed in a timely manner, as required by 21 CFR 820. I98(a)(l). For example:

a. Six customer inquiries (011952, 012027, 012072, 011966, 011913, and 012088)
that were received for warranty repairs on devices that were not working should
have been designated as complaints; however, the inquiries are not found in the
complaint log because the inquiry database has separate categories for "Warranty
Repair" and "Complaints". The complaint-handling procedure, SOP No.
505001, does not clearly define the categories used by Customer Service to
ensure that all complaint inquiries are correctly classified in the Made to Manage
database as such.

b. The trend report created for timing module issues for PTS devices identified 57
complaints received through February 2009; however, the report does not include
six complaints (011249, 011599, 011763, 012070, 012007, and 012013) that
were received for timing module defects.

c. Complaints 011249, 011706, and 011726 were received for timing drift failures
of PTS ISU devices, and the complaint investigations incorrectly conclude that
the devices were manufactured with timing modules that were manufactured
prior to CAPA 08-04. CAPA 08-04 was opened on April I, 2008 due to complaints of faulty timing modules.

Your response, dated June 16,2009, addressing revisions to the complaint-handling
procedure is inadequate in that the procedure is not yet complete and is not included with
the response for review. In addition, the response states that CAPA 08-04 was opened to
address failure to cycle issues with the PTS ISU devices not timing drift issues, but the
response does not address the incorrect conclusions that were listed in the complaint
investigations for complaints 011249, 011706, and 011726. These investigations
incorrectly concluded that the devices involved were manufactured prior to CAPA 08-04
when a new version of the timing module was introduced. The new CAPA 09-04 that
was opened during the May 2009 inspection to address these issues is still in process and
will need to be evaluated during a follow-up inspection.

4. Failure to document acceptance activities as required by 21 CFR 820.80(e). For
example, in March 2009, 464 incoming bottles (part # 6700-0209-500) were
received, visually inspected, and measured for wall thickness. There is no
documentation to show inspectional results including values for measured wall
thickness and results of the visual inspection; results are simply reported as passing.

Your response, dated June 16,2009, addressing proposed revisions to procedures for
incoming inspection, is inadequate in that the procedure is not yet complete and is not
included with the response for review. In addition, a new procedure governing Good
Documentation Practices, SOP 505057, was created, but it is not yet implemented and
was not included with the response for review.

5. Failure to establish and maintain procedures to ensure that device history records for
each batch, lot, or unit are maintained to demonstrate that the device is manufactured
in accordance with the device master record as required by 21 CFR 820.184. For

a. The device history records for PTS ISU devices do not reference on the material
record the OTS assembly component, including the receiving of the component,
the use of the component, or the number that are used. The OTS assembly is used
to set the vacuum for the devices and was outsourced to a contract manufacturer
in the fall of 2008.

b. The device history records for PTS ISU devices do not include the values for the
measured quantities for all parts of QC release testing. Specifically, quantitative
measurements must be made for testing such as final set point, leak tests, flow
determinations, gauge accuracy and occluded on/off time; however, the device
history record for PTS ISU, Lot ISU097012 has results that are recorded as pass.
In addition, Lot ISU0970678 found that Serial Number JGGN06094 failed the
test for intermittent timing; however, the device history record only shows the
result as failing and does not document the observed result.

Your response, dated June 16,2009, is inadequate in that the proposed corrections are
not detailed or complete to evaluate for adequacy. Specifically, a review of device
history records against device master records has not yet been completed, and a new
procedure governing Good Documentation Practices, SOP 505057, was created, but it is
not yet implemented and was not included with the response for review. In addition, the
effectiveness of the re-training that was performed regarding the Device Final Audit
procedure, SOP 505026, will have to be verified during a follow-up inspection.

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 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 ofhow you plan to prevent these violations, or similar violations, from
occurring again. 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 corrections will be completed.

Your response should be sent to: Carrie Ann Plucinski, Acting Compliance Officer, at
550 West Jackson Blvd., 15th Floor, Chicago, Illinois 60661. If you have any questions
about the content of this letter please contact Ms. Plucinski at (312) 596-4264.

Finally, you should know that this letter is not intended to be an all-inclusive list of all 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, 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.




Scott J. MacIntire

District Director