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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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M & S Acquisition 01-Nov-06

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

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771




November 1, 2006

WARNING LETTERs
CIN-07-31627-03

VIA FEDERAL EXPRESS

William S. Kilroy II
CEO/Chairman
M & S Acquisition Co., LLC dba Miltronics & Skye
9470 Pinecone Drive
Mentor, OH 44060-1863

Dear Mr. Kilroy:

During an inspection of your medical device manufacturing facility located at 9470 Pinecone Drive, Mentor, OH on September 11 through 27, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures orthopedic implantable devices, including lumbar bone screws, rods, nuts and plates. 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 manufacturing, 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 Ronald L. Bate, Quality Assurance/ Regulatory Affairs Manager, dated October 13, 2006, concerning our investigator's observations noted on the Form FDA 483, 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) Changes to methods and procedures needed to correct and prevent identified quality problems have not been fully validated and are not effective. [21 CFR 820.100(a)(4 and 5)]

Specifically, your firm opened seven separate corrective action reports, between March 9, 2006 and August 1, 2006, to address failures of a spinal fixation device to pass the torque test. None of the three different corrective actions that you implemented to fix this problem were effective and the actions implemented were not properly validated. This problem has not yet been resolved.

We have received your response and have concluded that it is inadequate because it does not address how your firm will assure that changes made as a result of a corrective or preventive action will be verified and/or validated to assure that the fix is adequate. Your response only addresses performing the process validation on the swaging process.

2) Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test. [21 CFR 820.75(a)]

Specifically, the following processes have not been adequately validated: the passivation process; which is performed using the [redacted] machine; the swag process; and the cutting, milling and threading processes which are performed by [redacted]. Computerized Numeric Controlled (CNC) machines, [redacted] horizontal CNC machines, and one threading rolling machine.

Your response does not ensure that the upcoming validation of the passivator includes worst case testing in regard to a number of devices. It also does not ensure that the most difficult devices to manufacture are going to be validated on the machines listed above.

3) Failure to establish procedures and failure to monitor and control the process parameters for validated processes to ensure that the specified requirements continue to be met. [21 CFR 820.75(b)]

Specifically, the pH, temperature, and specific gravity for the passivation process are not monitored; and the FDA investigator observed the specific gravity to be out of the required specification. Additionally, the temperature on the ultrasonic cleaning machine is not monitored.

Your response to this observation appears to be adequate.

4) Failure to include in the device history records complete acceptance records that demonstrate the device is manufactured in accordance with the device master record. [21 CFR 820.184(d)]

Specifically, nine of the 17 device history records reviewed were incomplete; had discrepancies in the number of devices in the lot, did not show all final acceptance tests were performed, and/or show out of specification test values.

Your response to this observation appears to be adequate.

5) Failure to adequately control products that do not conform to specifications. [21 CFR 820.90(a)]

Specifically, during the inspection, the FDA investigator found eleven non-conforming spinal fixation device assemblies in the manufacturing area with no identification.

Your response to this observation appears to be adequate.

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 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 within fifteen (15) working days from the date you receive this letter of the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation for the corrective actions you have taken. For the corrective actions listed in your response that appeared adequate, we will evaluate the adequacy of their implementation during the next FDA inspection. If corrective action cannot be completed within the timeframes specified in your letter, state the reason for the delay and the timeframe within which the-corrections will be completed.

Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.

Finally, you should know that 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 the 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 action to correct the violations and to bring your products into compliance.

Sincerely,

/S/

Carol A. Heppe
District Director
Cincinnati District