• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Spacelabs Healthcare Incorporated 03-Nov-08

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

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 96021-4421

Telephone: 425-486-8788
FAX: 425-483-4996

November 3, 2008

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 09-03

David Tilley
Chief Operating Officer
Spacelabs Healthcare Incorporated
5150 220th Avenue SE
Issaquah, Washington 98029-6834

Dear Mr. Tilley:

During an inspection of your firm located at 5150 220th Avenue SE, Issaquah, Washington, on April 15-18, April 22, April 24-25, April 29, May 1, May 7, and May 9, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient monitors and telemetry equipment for remote monitoring. 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 responses from you dated June 27, July 25, August 28, 2008, and September 26, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you. Your responses provided a Corrective and Preventive Action Report-(CAPA) for each observation. The CAPAs included future completion dates for each observation as to when corrective actions would be completed. We address your responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to adequately establish and maintain procedures for reviewing and evaluating complaints to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR § 820.198(a). For example:

a. Your complaint database indicated that (b)(4) complaints were open for more than 90 days, of which (b)(4) complaints were open for more than 500 days. The Complaint Handling Procedure 2101-159, Rev K, section 5.5.4, states that complaints should be closed within 90 days.

b. Complaints addressing the same issue are inconsistently prioritized. Your firm received six complaints describing "channel switching," however, the priority of complaints SL- (b)(4) SL- (b)(4) SL-(b)(4) and SL- (b)(4) was classified as a "2," while complaint SL- (b)(4) was classified as a "3," and complaint SL- (b)(4) was classified as a"4."

c. Your firm failed to establish complaint files for complaint SL- (b)(4) SL-(b)(4) SL-(b)(4) and SL-(b)(4) demonstrated by the fact that the (b)(4). Database tracking numbers could not be located and the records for these complaints were not available at your firm.

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses state that you retrained employees to ensure that parent and child complaints have the same priority rating, included reports of aging complaints at management review meetings, began review of overdue complaints, and revised your Complaint Handling Procedure. However, you have not implemented the procedure according to your firm's responses. In addition, your firm has indicated that you will complete additional corrective and preventive actions in the future. Please provide evidence that the revised Complaint Handling Procedure and the additional corrective and preventive actions have been implemented.

2. Failure to adequately establish and maintain complaint procedures which include a record of the complaint investigation, as required under 21 CFR § 820.198(e). For example, lab notebook pages or references to lab notebooks which document investigations were not included in the investigation documentation, as required by the Complaint Handling Procedure 2101-159, Rev K, section 5.2.6:

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses state that you retrained employees to ensure that investigation documentation is documented for complaints and that you revised the Complaint Handling Procedure. Please provide evidence that
the revised Complaint Handling Procedure and the additional corrective and preventive actions have been implemented.

3. Failure to adequately establish and maintain procedures for implementing corrective and preventive actions by failing to implement and record changes in methods and procedures that correct and prevent identified quality problems, as required by 21 CFR § 820.100(a)(5).

For example, your firm opened CAPA 69534 to address the disqualification of customer feedback as complaints. The corrective action for the CAPA included the implementation of (b)(4) (b)(4) Process for Product Specialists," dated December 21, 2007, which requires the Technical Support Manager's review of customer feedback disqualified as complaints by Product Support Specialists. As of December 21, 2007, there have been 12 such disqualified complaints recorded by Product Support Specialists that have not been reviewed by the Technical Support Manager.

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses state that you have conducted a retrospective review of all customer feedback and converted reports to complaints when appropriate, Please provide a summary of your retrospective review that describes the results of your investigation of your firm's review of customer feedback. In addition, please explain the corrective and preventive actions (e.g., employee training) that you will implement to address this deviation.

4. Failure to establish procedures for implementing preventive actions, as required by 21 CFR § 820 .100(a).

For example, the Failure Investigation and Corrective Action Procedure 2102-031, Rev K, does not address preventive actions.

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses state that you have retrained employees to ensure that they are aware of the requirements to document preventive actions. You also state that your firm will harmonize all procedures, specifically "Failure Investigations and Corrective Action" and "Complaint Handling" to require the documentation of preventive actions. Please provide revised procedures that harmonizes the requirement to document preventive actions and the additional corrective and preventive actions that you implement to address this deviation.

5. Failure to adequately establish and maintain procedures for conducting quality audits, as required by 21 CFR § 820.22.

For example, your firm's Internal Audit and Review SOP requires that your firm maintain a current audit schedule. The Audit Schedule for 2006 did not include the audit scheduling, completion, or closure dates for the Data Analysis Complaints, Audits, or CAPA areas.

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses provided the Internal Audit and Review Procedure 2101-116 and the 2008/2009 schedule for the Data Analysis Audits. In addition, your responses state that additional corrective and preventive actions will be completed in the future. Please provide evidence that the revised Internal Audit and Review Procedure, 2008/2009 Data Analysis Audit schedule, and the additional corrective and preventive actions have been implemented.

Our inspection also revealed your devices are misbranded under section 502(t)(2) of the Act, 21 USC § 352(t)(2), because your firm failed or refused to furnish material or information respecting the device which is required by or under section 519 of the Act, 21 USC § 360i, and 21 CFR, Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following :

1. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information which reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR § 803.50(a}{1).

For example, your firm failed to submit complaints SL-(b)(4) SL-(b)(4) and SL-(b)(4) to FDA within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that the device may have caused or contributed to a death or serious injury. These complaints described one death SL-(b)(4) and two serious injuries -- SL-(b)(4) involved a hypoxic episode resulting in subsequent heart failure and brain damage, and SL-(b)(4) involved an asystolic episode requiring resuscitation.

2. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information which reasonably suggests that a device that you market has malfunctioned and that this device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR § 803.50(a)(2).

For example, your firm failed to submit complaint SL-(b)(4) and SL-(b)(4) to FDA within 30 days of becoming aware of information that reasonably suggested that the device had malfunctioned. The dates the events were reported for complaints SL-(b)(4) and SL-(b)(4) were November 23, 2006, and November 27, 2007, respectively; however, MDRs were not submitted to FDA until June 2008.

Your firm's responses dated June 27, July 25, August 28, and September 26, 2008, are inadequate. The responses agree that your firm did not report the events within the 30-day requirement. Your firm submitted MDRs for each of the five complaints on June 16, 2008. However, your responses state that you are conducting a retrospective-review of complaints submitted since January 1, 2005, to determine if any additional MDR reports should be filed, and to date, this has not been provided. Further, your firm did not provide documentation showing that personnel have been adequately trained on the MDR procedures and that these procedures have been successfully implemented. Please provide this information for our review.

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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil 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, no premarket submissions for Class Ill devices to which QS regulation deficiencies are reasonably related will be cleared 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 to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within fifteen (15) working days, please state the reason for the delay and the time within which the corrections will be completed. Also, documentation showing plans for correction should be included with your response to this letter.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. 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, 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 cause of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23d Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.

Sincerely,

/S/

Charles M. Breen
District Director