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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medron Inc. Response Letter

   

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

Public Health Service
   

December 19, 2003

 

Mr. William H. Sherer, Compliance Officer
Food and Drug Administration
Denver District Office
Bldg. 20 - Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087

Dear Mr. Sherer:

This letter is being written in reply to the Warning Letter, DEN-04-02, received by Medron, Inc., dated December 3, 2003. Medron, Inc. takes all of the quality systems issues raised by the Food and Drug Administration seriously. It is our intent to fully cooperate with the Agency in addressing these issues and assuring that we comply with the Quality Systems Regulation to the highest level possible.

At the time of the FDA inspection (August 25-29, 2003), Medron Inc., an OEM supplier of assemblies, had already recognized the need to enhance their quality assurance knowledge, skills and experience due to their rapid growth and had recently hired Mr. Ed Goodman to lead this effort as the head of the Quality Assurance organization . Mr. Goodman came to Medron on 06/23/2003 and has extensive experience in the medical device industry (See Mr. Goodman's curriculum vitae, Attachment A). Mr. Goodman has been assigned by management with executive responsibility (Mr. Ron Wortley, President) to be the Management Representative for the firm and this responsibility is reflected in Medron's revised Quality Manual and Organizational Chart. Mr. Goodman will continue the process of assessing the quality and compliance needs of Medron and has already begun making improvements, including strengthening the quality organization by assigning responsibilities in job descriptions, revising Medron's Quality Manual, and assessing the need to hire additional resources.

Other changes that Medron, Inc. has made or is in the process of making are detailed in this response. Where Medron, Inc. procedures already existed at the time of the FDA inspection but required enhancement, these procedures have been revised to ensure full compliance with the respective Quality Systems Regulations in 21 CFR 820 (for example [redacted]. Where Medron, Inc. lacked procedures to comply with certain aspects of 21 CFR 820, procedures have been written (for example [redacted]. In all cases, appropriate personnel who must utilize these procedures have been identified and either have been or will be trained to assure fulfillment of the requirements of the Quality Systems Regulation. 

The following pages provide the actions already taken, the actions planned and completion dates to address the issues referenced in the December 3rd Warning Letter and any objective evidence to substantiate Medron's current level of compliance. As further enhancements to the quality system are made and additional evidence becomes available, they will be documented in future updates to this response which will be provided to you on a monthly basis until all of the actions discussed in this response are completed. Medron is also committed to further reviewing all of our Quality Systems to determine areas to concentrate our activities to assure continuous improvement.

We believe that these responses will bring Our facility into full compliance and address all of the Food and Drug Administration's concerns. Should you require any clarification or further information, please contact me at (801) 974-3010.

Sincerely,
/s/
Ron W. Wortley, President

___________________________

 

Observation 1:

Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria prior to being released for distribution, as required by 21 CFR820.80(d). Specifically a review of 35 Device History Records (DHR) revealed [redacted] lots of product that were released without complete manufacturing testing results, a Certificate of Conformance or a Shipping Release form.

Response:
Device History Records (DHR) reviewed at the time of the investigation contained the appropriate information; however, the customer document packet was not appropriately completed to reflect the test data that was available. Nevertheless, a new procedure, [redacted] has been written (see Attachment 1a) to strengthen Medron's review of and to define the acceptance requirements to ensure that DHR documents are thoroughly reviewed for completeness and accuracy prior to a production run, lot or batch being released. In addition to the requirements of this procedure, the Quality Assurance Manager is now reviewing [redacted] all DHR documents to ensure that they are being completed. (Reference [redacted] see attachment 1e). (Also see Attachment 1b and 1c, forms [redacted]. Employees involved in device history records have been trained on the new procedure [redacted] which was effective on [redacted] (See Attachment 1d).

Scheduled Completion Date: [redacted]

Status: [redacted]

Attachments:
la- [redacted]
1b - [redacted]
1c -[redacted]
1d - Employee Training Record
1e - [redacted]

Observation 2:

Failure to establish and maintain procedures which address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). Inherent in the evaluation of nonconformance is the assessment of risk and determination of the need for an investigation.

A review of DHRs, Non-Conforming Materials Reports (NCMR) and Corrective and Preventive Action (CAPA) records revealed instances of: no record of the disposition of nonconforming product, lack of justification for not conducting a failure investigation, lack of CAPA determination, and lack of evaluation/assessment of risk.

Response:

Procedure [redacted] have been revised to ensure that the requirements for documentation, evaluation, segregation and disposition are clearly stated (see Attachments 2a and 2b). Assessment of risk and determination of the need for an investigation are key components of the new procedure's flow chart and the linkage between the Control of Nonconforming Product and the Corrective and Preventive Action System has been defined in [redacted]. As stated in the response to observation 1, the Quality Assurance Manager or designee is reviewing [redacted] of all DHR documents (including any NCMRs or CAPA records) to ensure that they are being completed and include any dispositioning of product as a result of these records. Personnel training is expected to be completed by [redacted] and the training documentation will be forwarded to the Agency in Medron's [redacted] status report.

Scheduled Completion Date: [redacted]
Status: [redacted]
Attachments:[redacted]
:
2a [redacted]:
2b [redacted]:

Observation 3:

Failure to establish and maintain procedures for rework, to include re-testing and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). Rework and reevaluation activities, including a determination of any adverse effect from rework upon the product, must be documented in the DHR.

A review of DHRs and NCMRs that referenced the need for rework did not always include or reference validated procedures to be used to perform the rework. In addition, there was no written requirement to validate rework procedures.

Response:

Medron has created a new procedure, [redacted]. (See Attachment 3a and 3b) that include requirements that rework processes must be verified/validated as appropriate and that the rework must include documentation in the DHR of any adverse effect from the rework activities on the product. In addition, [redacted] assure that any rework required to bring product(s) into conformance with acceptance criteria, requires risk assessment of sorting and rework activities and that rework documentation is reviewed for completeness, accuracy and any adverse impact(s) as part of the dispositioning phase (See Attachment 3c, 3d, 3e and 3f). In addition to the requirements of this procedure, the Quality Assurance Manager is reviewing [redacted] of all DHR documents to ensure that they are being completed in a comprehensive and accurate manner before the products are released. Appropriate personnel have been identified and will be trained on the above-mentioned SOPs by [redacted]

Scheduled Completion Date: [redacted]
Status: [redacted]
Attachments:
[redacted]
3a - [redacted]
3b- [redacted]
3c- [redacted]
3d - [redacted]
3e - [redacted]
3f - [redacted]

Observation 4:

Failure to establish and maintain procedures for implementing corrective and preventive action as required by 21 CFR 820.100, including requirements for:
a. Analyzing quality data, including complaints, product non-conformance and reject forms, and CAPAs, to identity existing and potential causes of nonconforming product, using appropriate statistical methodology, such as trend analysis;
b. Identifying actions needed to correct and prevent recurrence of non-conforming product, and;
c. Verifying or validating the corrective and preventive actions, such as changes in manufacturing processes, to ensure that these actions are effective and do not adversely affect the finished device.

Response:

The [redacted] and the procedure [redacted] and the associated [redacted] have been revised to ensure that when quality systems (complaints, nonconforming product reports, rejections, etc.) are not effective in correcting and preventing recurrence of quality issues, the [redacted] must be used to identify additional actions which need to be taken and to provide for verification/validation of corrective and preventive actions to assure that they are effective and do not adversely affect the finished device (See Attachment 4a, 4b and 4c). Trend analysis of quality data to identify actions which need to be taken and verification/validation of corrective and preventive action to assure adequate analysis is performed and appropriate actions are taken is defined by [redacted] (See Attachment 4d). In addition, [redacted] has been revised to assure adequate awareness and review by management of any adverse trends in quality data and to ensure that the quality system continues to operate in compliance. (See Attachment 4e).

To assure that changes including those for manufacturing processes, are verified or validated where appropriate and to confirm that these actions are effective and do not adversely affect the finished device, [redacted] have all been revised. These revisions enhance the requirements for validations and properly reflect the regulations (See Attachments 4f, 4g, and 4h).

Appropriate personnel have been identified and have been (See Attachment 4i) or will be trained on the above-mentioned SOPs by [redacted]

Scheduled Completion Date: [redacted]
Status:
[redacted]

Attachments:
4a- [redacted]
4b- [redacted]
4c - [redacted]
4d - [redacted]
4e- [redacted]
4f - [redacted]
4g - [redacted]
4h - [redacted]
4i - Training documentation for [redacted]

Observation 5:

Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules.
Specifically:

a. Maintenance procedure for the [redacted] calls for [redacted]
b. Maintenance procedure for the [redacted] calls for [redacted] inspections and [redacted] maintenance;
c. Maintenance procedure for the [redacted] requires cleaning and lubrication at [redacted]

Maintenance records indicate that these schedules are not adhered to, as required by 21 CFR 820.70(g)(2) and 21 CFR 820.72(a).

Response:

For the records identified in Observation 12 of FDA Form 483 issued to Medron, Inc. on August 29, 2003, where preventive maintenance was identified as being overdue, the equipment maintenance has now been brought up to date and is being maintained in accordance with Medron's procedures. [redacted] (See attachments 5i, 5j and 5k).

Medron's procedure for [redacted] has been revised to require a written schedule for maintenance, adjustment and/or cleaning of equipment. This schedule is recorded on [redacted] and the performance of the maintenance is recorded on [redacted] (See Attachments 5a, 5b, and 5c). In addition, the procedure for equipment qualification, [redacted] and its associated forms, [redacted] have been revised to require that preventive maintenance is addressed as part of the equipment's IQ/OQ. (See Attachments 5d, 5e, and 5f).

Personnel involved in equipment preventive maintenance have been identified and trained on these new procedures. (See Attachment 5g).

The [redacted] is responsible for completing the requirements outlined in these SOPs and associated forms; however, to ensure more consistency with these requirements, a [redacted]

Scheduled Completion Date: [redacted]
Status: [redacted]

Attachments:
5a - [redacted]
5b - [redacted]
5c - [redacted]
5d - [redacted]
5e- [redacted]
5f - [redacted]
5g - Training documentation for SOPs
5h - [redacted]
5i - Maintenance Record
5j- Maintenance Record
5k-Maintenance Record

Observation 6:

Failure to review, evaluate and investigate all complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c).

Specifically, your firm's procedure requires that you perform a [redacted] on the problem, if one exists. A review of your complaint files revealed that these requirements were not being accomplished in all cases.

Response:

Medron's [redacted], and its associated form, [redacted] have been revised to include the requirements to review, evaluate and investigate all complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications as per 21 CFR 820.198(c) (See Attachment 6a and 6b). These changes in the complaint handling system ensure that when a complaint is confirmed or an adverse trend is identified appropriate action is taken such as documented evidence that [redacted] to assess the risk and to correct and/or prevent recurrence of any deficiency. When the complaint handling system fails to address the recurrence of these deficiencies. [redacted] procedure is provided. (See Attachment 6c).

Appropriate personnel have been identified and will be trained by [redacted]

Scheduled Completion Date: [redacted]
Status: [redacted]

Attachments-
6a - [redacted]
6b - [redacted]
6c- [redacted]

Observation 7:

Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization as required by 21 CFR 820.20(a). For example, management with executive responsibility has not maintained an adequate organizational structure to prevent the quality system deviations as identified on the Form FDA-483.

Response:

At the time of the FDA inspection (August 25-29, 2003), Medron had already recognized the need to: enhance their quality assurance and compliance knowledge, skills and experience due to their rapid growth and had recently hired Mr. Ed Goodman to lead this effort as the head of the Quality Assurance organization. Mr. Goodman came to Medron on [redacted] and has extensive experience in the medical device industry (See Mr. Goodman's curriculum vitae. Attachment 7a). Mr. Goodman has been assigned by management with executive responsibility (Mr. Ron Wortley) to be the Management Representative for the firm and this responsibility is reflected in Medron's revised Quality Manual and Organizational Chart and in [redacted] Management Responsibility (See Attachment 7b, 7c, 7d). Mr. Goodman is examining the quality and compliance needs of Medron and has already begun making improvements, [redacted]. The quality/compliance assessment process is on-going as business needs change. The initial assessment of requirements for 2004 has been completed. Also attached (7f) you will find Medron's Scheduled Training program.

Scheduled Completion Date: December, 2003
Status: Complete
Attachments:

7a - Mr. Ed Goodman's Curriculum vitae
7b - Excerpt from Quality Manual showing appointment of Mr. Goodman as Management Representative
7c - Current Organization Chart showing [redacted]
7d - [redacted] Management Responsibility
7e - Management Representative job description
7f - Scheduled Training Program