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U.S. Department of Health and Human Services

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Enforcement Actions

Microsulis Medical Ltd. , 11/20/09

   

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

Public Health Service
Food and Drug Administration
  10903 New Hampshire Ave
Silver Spring, MD  20993


WARNING LETTER

 

NOV 20,  2009

Mr. Stuart McIntyre
Chief Executive Officer
Microsulis Medical Limited
Parklands Business Park
Denmead Hampshire PO7 6XP
United Kingdom

Dear Mr. McIntyre:

During an inspection of your firm located in Denmead Hampshire, United Kingdom on July 6, 2009, through July 9, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures microwave endometrial ablation and microwave tissue ablation devices. 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 your response dated July 23, 2009, concerning our investigator's observations noted on the Form FDA 483, List of 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. Failure to establish and maintain adequate procedures for corrective and preventive action to ensure analysis of processes have occurred to identify existing and potential nonconforming product and to implement and record changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a).

For example:

a. You introduced the Fernwave single use applicator in 2005. You used the same (b)(4) testing criteria that had been established for the reusable applicator. You determined that there were differences in the properties of the single use and re-usable applicators, this resulted in the issuance of CAPA in 2006.

•The CAPA identified the plastic sheath thickness as a contributor to process variability but no corrective action was initiated for this potential root cause identified.

• You continue to have nonconformance rejects for not meeting the (b)(4) or (b)(4) testing. The device history showed that 11 of the (b)(4) batches reviewed included some nonconformances. Data analysis for these nonconformances has not been performed and there has been no additional evaluation as to whether this data should initiate a new CAPA to address the existing nonconformances.

• A review of the statistical process control sheets for the (b)(4) test for three of the batches showed that the process is not operating in a state of control. The control charts for Lot 09230001 showed that the process regularly exceeded the control limits and the limit is not met at times.

• Data analysis for these nonconformances has not been performed and there has been no additional evaluation as to whether this data should initiate a new CAPA to address the existing nonconformances.

b. Returned product is not being analyzed for identification for existing or potential nonconformances.

We have reviewed your response  dated July 23, 2009, and have concluded that it is inadequate. Although you promised to correct the problem and indicated that you would open a CAPA to address nonconformances,you did not provide specifies to the corrections or  address systemic corrective actions to ensure the CAPA process is effective and is in compliance with the regulatory requirements. Also, you did not provide documentation of the promised corrections.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198.

For example, four out of eighteen return records reviewed from the log book (return numbers: 011481, 011795, 011886, and 011565) were due to various identified performance problems. None of the four were entered into your complaint system. Each of the four returns had been checked as not being a complaint.

We have reviewed your response dated July 23, 2009, and have concluded that it is inadequate because you stated that you will address procedures for handling non-conforming products in your updated SOP for Returns Process Procedure (b)(4) however, you have not provided the updated changes to the FDA.

3. Failure to establish and maintain adequate procedures for verifying the device design outputs meets the design input requirements, as required by 21 CFR 820.30(f).

For example, the Device History File (DHF) for the surface applicator study for the MTA product did not include documentation that acceptance criteria were established for the ex-bovine liver study that was used in determining the dimensional characteristics of the ablation zones.

We have reviewed your response dated July 23, 2009, and have concluded that is inadequate because you promised to re-examine the concerns related to the device history file for the surface applicator for MTA treatment (Exhibit 29-MTA Design Note to File). You also promised to repeat the tests described in the updated protocol [Protocol Number (b)(4)] and forward the results to the FDA. However, you have not yet forwarded the results to the FDA.

4. Failure to establish and maintain adequate procedures for validating the device design to ensure that devices conform to defined user needs and intended uses to include risk analysis, where appropriate, as required by 21 CFR 820.30(g).

For example, the design plan for the MTA Surface Applicator indicates that validation was completed on June 13, 2009; however, there was no documentation that the pre-determined user needs and intended uses were validated. A review of the risk analysis report and assessment stated that the hazard of thermal penetration beyond the target tissue would be mitigated by user training. There was no evidence of validation of the design for user needs and intended uses and no evidence that this risk was indeed mitigated.

We have reviewed your response dated July 23, 2009, and have concluded that it is inadequate because you promised to develop a protocol and conduct a clinical evaluation of the Applicator (Attachment 5-User Needs Document (b)(4)) in order to validate the design. You promised to forward the final report to the FDA upon completion.

5. Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

For example, your design control procedures did not include a procedure to ensure that design changes of existing products would include verification or where appropriate validation.

We have reviewed your response dated July 23, 2009. Your response appears to be adequate.

6. Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

For example not all areas of the quality system are being audited as prescribed by SOP Specifically. customer interfaces (including the complaint handling system) have not been audited since 2006. Control of nonconforming product and the CAPA system have not been audited since May 2007.

We have reviewed your response dated July 23, 2009, and have concluded that your response is inadequate because although you have provided a schedule for audit training for employees (training schedule dates: November 17 and 18, 2009-Attachment 7) and provided the revised audit schedule for 2009, (updated on July 17, 2009)-Attachment 8, the training has not been completed, nor have you provided documentation showing that an audit has been performed. Further, you have not provided a systemic corrective action to ensure all such quality audit areas will continually be audited according the established schedule.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381 (a)). Also, U.S. 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 fifteen (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 of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action 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 the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to: Paul Tilton, W066 Room 3540, 10903 New Hampshire Avenue, Silver Spring, MD 20993 USA. If you have any questions about the content of this letter please contact: Paul Tilton at 301-796-5770 or {fax} 1-301-847-8137.

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

Sincerely,

/s/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health