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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Troy Innovative Instruments, Inc. Response Letter

November 14, 2007

Compliance Office, Food and Drug Administration

Attention: Ms. Gina Brackett
6751 Steger Drive
Cincinnati, OH 45237

RE: CIN-08-34399-03

Dear Ms. Brackett:

In response to the letter dated November 1, 2007, enclosed please find our intention to resolve the violations noted. During and after our visit from Benjamin J. Dastoli (Investigator) for the FDA, we began working toward completing the violations he had noticed here at Troy Innovative Instruments Inc.

1) Validation of manufacturing processes - We are working to achieve conformance in this area. The delays are based on the following. We need to establish and write test protocols and parameters. Numerous tests must be carried out which will take time and manpower to accomplish. We will complete these test on schedule.

a) The ultrasonic cleaning and standard cleaning process, we intend to have it completed no later than 01/07/2008 (schedule enclosed).
b) The electro-polishing system will be validated by 01/07/2008 (schedule enclosed).
c) The CNC C-4 will be completed no later than 01/17/2008 (production timing).
d) The passivation system. will be validated by 12/24/2007 (schedule enclosed).
e) The heat-treating will be validated by 12/24/2007 (schedule enclosed).

2) Device History Records - Completed on 11/06/07, and have followed the evidence of its effectiveness since that date. We are pleased with the results.

a) We retrained all employees on device record keeping (training records enclosed). We stressed the importance of scrap counts and quantity discrepancies. We addressed the recording of time on the routers as proof of completion of work. We have trained the employees on our policy for recording out of specification results that require a manager's signoff.
b) We have two different managers reviewing the documentation on a daily basis.
c) We have implemented a disciplinary policy for poor record keeping

3) Analyze of data - Completed 11/09/07, through our management review meeting of l1/02/2007 we established the data to be used to better our quality system.

a) We have created means to track and analyze our scrap, based on cause, department and reason.
b) We have also set up a means to track and analyses non-conformances, through the use of a logging system.
c) Hold tags are also part of our data to be captured, through both the usage and the logging system.

4) Effectiveness of CAPA - Completed 10/26/2007.

a) We have changed our internal documentation to record the effectiveness of a corrective action and the track the root cause of any underlying issue for all products.
b) We have put into place a procedure to track these documents.

5) Non-conforming product control - Completed 11/06/2007.

a) We have established a procedure, which is part of our device history records training for Routing Sheets and IPIF forms. It requires approval and qualification of any out of specifications items, before the products can continue throughout the system.
b) We have limited the personnel that can handle the non-conforming process.

6) Inspection of products - Completed on 11/06/2007.

a) We have placed guidelines on product that arrive from an outside source and established tests and inspections.

7). Supplier evaluation - Partially completed 10/15/07 for survey portion. The qualifications should be completed within 3 months from date of this correspondence The final ratings will be given at the end of 2008.

a) We are following our written procedure to qualify our suppliers of value added services, we have tracked their shipment of products since 10/15/07 for qualification.
b) We have sent out Supplier Survey's and have received most all of them back.
c) We have activated tracking on each new shipment as of 10/26/2007 from our suppliers, to give them a quality rating by the end of next year.

8). Audits - Working on schedule, should be completed no later than the end of the 1st quarter of 2008

a) We had provided for Benjamin a list of quality management procedure that we scheduled to audit by the end of this year.
b) We have a firm schedule to complete all the Quality Management Procedures and processes by the 1st quarter of 2008.

9). Management Review - Ongoing, however the schedule has been set and the staff is on track. We will continue to hold the meetings as stated in our management procedure.

a) We had a management review meeting on November 2, 2007. Management will continue to have a monthly meeting in the short term until all the issues with the FDA are resolved and the projects we have committed to are resolved.
b) We will return to having our bi-annual meetings as we had stated in our management procedure

In conclusion I would like to state that Troy innovative instruments, Inc takes great pride in the work we do. We are committed to working toward achieving these goals and satisfying both the FDA and our customers requirements.

Regards,

/S/

Tracy Stowe

Xc: Thomas Cseplo / President Troy Innovative Instruments, Inc.
FDA File copy