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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warsaw Orthopedic Inc 01-Oct-07

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

Public Health Service
Food and Drug Administration


Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139



November 4, 2005

Dominic F. Presty,
Vice President of Manufacturing Operations
Warsaw Orthopedic Inc
dba Medtronic Sofamor Danek
2500 Silveus Crossing
Warsaw, IN 46582-8598

Dear Mr. Presty:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility on September 19, 2005 through September 23, 2005. The purpose of the inspection was to evaluate the adequacy of your activities related to the Atlantis Element Express Kit, LT CAGE lumbar tapered fusion device, and the METRx MED manufactured by your firm. These spinal fixation products are devices as defined by Section 201(h) (21 U.S.C. 321(h)) of the Federal Food, Drug, and Cosmetic Act (the Act).

Our inspection revealed that these devices are adulterated within the meaning of Section 501(h) (21 U.S.C. 351(h)) of the Act, in that the methods used in, or the facilities used for the manufacture/assembly, packing and storage of these finished medical devices intended for hum an use, are not in compliance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1. Failure to verify design outputs meets desi gn inputs, as required by 21 CFR 820.30(f). For example, you have not ve rified whether the following production changes have affected the device design.

a) A temporary change to a Work Order for the LT CAGE implantable device was implemented prior to verifying whether desi gn output meets design inputs. As a result, some sterilization steps were omitted causing non-sterile lots of product to be released and in some cases implanted into patients.

b) Your implementation of the incoming QC acceptance test for the screwdriver shaft item #786-101 of the Atlantis Element Express Kit (hex head end) included overlay technology which was found to give incoming items a "pass result" at [redacted] magnification, whereas other comparative exams found these items to be~out of specifications.

2. Failure to perform or document verification or validation of production process changes, as required by 21 CFR 820.70(b). For example, temporary or permanent changes made during production processes were not verified or validated prior to implementation.

3. Your Corrective and Preventative Actions (CAPA) system violates 21 CFR 820.100(a)(4), which requires verifying or validating a CAPA action to ensure that such action is effective and does not adversely affect the finished device. For example, CAW06014, initiated on 5/31/05, and CAW05114, initiated on 1/6/05, do not include a determination of whether verification or validation is needed to prevent recurrences in order to assure the corrective action was effective and would not adversely affect the finished product.

4. Failure to document CAPA activities as required by 21 CFR 820.100(b). For example, your CAPA system does not require raw data generated during a CAPA investigation to be maintained.

5. Failure to maintain records as required by 21 CFR 820.180. CAPA investigations initiated as a result of a management review or internal audit are not maintained.

6. Failure to provide training to ensure employees adequately perform their assigned responsibilities as required by 21 CFR 820.25(b). For example, you have not assured that personnel are adequately trained to perform assigned functions.

The letter is not intended to be an all-inclusive list of your firm's compliance status. It is your responsibility to assure adherence to each requirement of the federal regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of illegal products, the assessment of civil money penalties, and injunction against the manufacturer and/or distributor of illegal products.

We acknowledge receipt of the October 14, 2005 letter responding to the FDA-483 issued at the conclusion of the September 19-23, 2005 inspection. We understand that time frames for completion of the assessment of these problems remain. However, our comments to the responses are as follows:

Regarding the design control requirements; your response to this observation questions the category of the observation stating the nature of the item is an element of production and process controls per 820.70(b). The response further explains that "Design control pertains to the design of the physical product used by the customer. Process control pertains to the establishment of the manufacturing controls necessary to ensure that the product design requirements are met."

We agree with your statement, but we believe you have misinterpreted the regulations. What we believe this observation is saying is that any changes found or made during production processes can affect the device specifications or the design requirements. By your firm making temporary or permanent changes to production processes, we believe you have changed the physical product and have not verified or ensured fhat the design requirements/specifications have been met or maintained. You have not addressed this issue.

Regarding the deficiencies noted to changes in procedures, we accept your revised procedures and forms. However, the established corrective actions post-date the timing of the causative events to the problems with releasing non-sterile and out-of-specification devices subject to the September 2005 inspection and this warning letter. In addition, your re onse mentions the company will be upgrading the entire process change control system with the [redacted] software. We encourage you to evaluate whether this revised software would need to be validated.

Regarding CAPA records, to our understanding the CAPA records requested by the investigator were not readily available for review. Every effort must be made to ensure records are available upon request. Records not maintained represent a CAPA activity that has not been documented. In addition records not provided upon request due to company policies (specifically records relating to CAPA activities) may represent a refusal to the FDA, under Section 301(f) (21 U.S.C. 331(f)) of the Act.

Please notify this office in writing within fifteen (15) working days of your receipt of this letter, of any additional steps you plan to take to bring your firm into compliance. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time frame which the corrections will be implemented. Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address.



Joann M. Givens
District Director
Detroit District Office