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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Philips Medical Systems 29-Jan-07

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 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4760




January 29, 2007

CERTIFIED MAIL
RETURN RECEIPT REQEUSTED

In reply refer to Waning Letter SEA 07-08

Mr. Charles A. Little
General Manager
Philips Medical Systems
2301 5th Avenue, Suite 200
Seattle, Washington 98121

WARNING LETTER

Dear. Mr. Little:

During an inspection of your firm located in Seattle, Washington, conducted from August 15; 2006, through September 14, 2006, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following models of Automatic External Defibrillators (AEDs): FR2/FR2+, FRx, and HS1 models. 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 (C.F.R.), Part 820. We received a response from Mr. Dennis Daniels, Sr. Manager, Quality Assurance, dated September 29, 2006, 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 procedures adequate for implementing corrective and preventive actions that include requirements for identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 C.F.R. 820.100(a)(3).

For example:

a. A review of complaints documented a total of [redacted] intermittent switch failures in FR2/FR2+ model AEDs reported by users, all with printed circuit board assembly (PCBA) date codes prior to 0305 (third week of year 2005). [redacted] of these [redacted] failures were for critical switches (i.e., the "On/Off and "Shock" switches). Your investigation (CAPA 06204) attributes these failures to a manufacturing problem involving wash water contamination within the switches. Although you took action in-house to prevent further distribution of devices with potentially, contaminated switches, you did not identify plans to take any field corrective action to prevent recurrence of this problem in units already distributed.

We have reviewed your written response and have concluded that it is inadequate because you do not plan to take action to correct units in the field suspected of having this problem. Rather, you only plan to continue to monitor problems in the field. To discuss this issue further, you met with CDRH on December 7, 2006. During this meeting, you agreed to notify users of this intermittent switch problem and recall units.from affected lots. The agreed upon recall strategy adequately corrects this particular switch problem. However, your response is. still inadequate because (i) you have only addressed the specific correction and not made any corrective action, to the CAPA system that allowed this to occur, and (ii) no preventive actions have been submitted.

b. Complaints and service repair data document [redacted] cases of either the "On/Off" or "Shock" button not working on HS1 units (Onsite and Home models). The Rework Request records associated with these complaints and repairs conclude that [redacted] was either confirmed or considered the likely cause, which can occur during production. You retrained employees on the existing assembly procedure, but. took no action on units already distributed.

We have reviewed your response and have concluded that it is inadequate because you do not explain how retraining employees on the existing assembly procedures is expected to correct this problem, given that these same procedures were in place when the faulty units were manufactured. Further, you have not submitted any data on the potential for any remedial action for units already distributed. No system corrective actions nor preventive actions were submitted.

2. Failure to establish and maintain procedures adequate for acceptance of incoming product that include requirements to verify that incoming product conforms to specified requirements, as required by 21 C.F.R. 820.80(b).

For example:

a. Receiving Inspection Reports (RIRs) for [redacted] (parts no. [redacted] and PCBAs (part no. [redacted] show that receiving of these parts was accepted from suppliers that were not listed as approved sources for these parts.

We have reviewed your response and have concluded that it is inadequate First, you do not acknowledge that your employees should have rejected these parts under the written procedures in place at the time. Instead, your response justifies these actions by stating that these parts were received from acceptable sources (i.e., [redacted] was received from the PCBA supplier; who originally received it from the approved source; and the PCBAs were received from subsidiaries of the approved source), and states that the appropriate procedures have been updated accordingly. However, no system corrective actions were submitted with regards to a review of approved suppliers versus supplied product, and no preventive action was addressed.

b. RIRs for high voltage capacitors (part no.[redacted]) show that receiving of these parts was accepted without the required Certificate of Conformance (CoC) from [redacted] a distributor. This requirement is included in the inspection procedure for this part.

We have reviewed your response and have concluded that it is inadequate. First, you do riot acknowledge that your employees should have rejected these parts under the written procedures in place at the time. Your response justifies these actions by stating that [redacted] is no longer the approved supplier of this part, and states that the appropriate procedures have been updated accordingly. However, the response is inadequate because it does not address why obsolete procedures were being utilized, and no corrective or preventive actions designed to ensure that changes in approved suppliers will be timely updated in future were provided.

c. RIRs for PCBAs (part no.[redacted], show that receiving of these parts was accepted with CoCs that did not include the required lot numbers (specified in the inspection procedure for this part)

We have reviewed your response and have concluded that it is inadequate. First, you do not acknowledge that your employees should have rejected these parts under the written procedures in place at the time. Your response justifies these actions by stating that "work number" can be used in place of the "lot number," and states that the appropriate procedures have been updated accordingly. However; the response is inadequate because it does not address alternate acceptance procedures not included in your established procedures being utilized. No corrective or preventive actions were outlined.

d. A RIR for high voltage capacitors (part no.[redacted] and [redacted]) shows that receiving of these parts was accepted with a Quality and Conformity Affidavit that did not have any results recorded for product quality characteristics.

Your response to this observation appears to be adequate.

e. RIRs for high voltage capacitors (part nos. [redacted] and [redacted]) show that receiving of these parts was accepted despite the fact that the part revision numbers listed on the Quality and Conformity Affidavit did not match those listed on the RIR.

Your response to this observation appears to be adequate.

3. Failure to establish and maintain procedures adequate to ensure the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a).

For example:

a. PCBAs manufactured by [redacted] were found to have surface contamination, resulting in [redacted] finished FRx and HS1 units failing the final acceptance test. However, it does not appear that you have taken any steps to determine the actions that [redacted] should take to prevent shipping contaminated PCBAs.

We have reviewed your response and, have concluded that it is inadequate because no changes to the PCBA manufacturing procedure were implemented to reduce surface contamination. While you added the same [redacted] test at [redacted] {prior to PCBA shipment) as used during final acceptance testing of finished devices, the PCBAs continue to be manufactured using the same process the resulted in contaminated boards. Your have not adequately addressed the corrective action of adequately defining and controlling suppliers.

b. The receiving inspection procedures for a high voltage capacitor state that a CoC must be provided by [redacted] the approved supplier of this part. However, [redacted] is a former, distributor of this part, and the firm failed to update the receiving procedures to replace [redacted] with the name of the new supplier [redacted]

We have reviewed your response and have concluded that it is inadequate. While the inspection procedure has been updated to delete reference to [redacted] your response does not address any corrective and preventive actions to the system of purchasing controls and approved suppliers, nor does it address the issue of obsolete inspection procedures being utilized.

4. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 C.F.R. 820.50(b).

For example, the drawing for an integrated circuit (IC) part (i.e. [redacted]) requires the manufacture date, lot code, and CoC to be provided with each shipment. This part is a component of a PCBA that is manufactured for you by a second supplier. You do not verify that the required information for the IC part is received by the PCBA supplier.

We have reviewed your response and have concluded that it is inadequate because the required information for this IC part is neither reviewed by your firm nor verified to be reviewed by the PCBA supplier. You state that the PCBA supplier is contractually obligated to ensure that all of your part specifications are met, and receipt of a signed CoC from the PGBA supplier is taken as assurance that these obligations have been fulfilled. However, no purchasing procedures were provided in support of this statement.

Our inspection also revealed that your model FR2/FR2+ devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:

Failure to submit a written report to FDA of any correction or removal of a device initiated by such manufacturer if the correction or removal was initiated (1) to reduce a risk to health posed by the device, or (2) to remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the correction or removal action is exempt from the reporting requirements under 806.1(b), as required by 21 C.F.R. 806.10(a).

For example, your investigation of intermittent switch failures of FR2/FR2+ AEDs (CAPA 06204) attributes these failures to a manufacturing problem involving wash water contamination within the switches. Although you have not initiated corrective action for distributed units, you did initiate internal corrective actions to prevent contaminated switches from being distributed. Specifically, these additional actions include, [redacted] after the washing step, and performing [redacted] as part of the final testing of the devices. Since intermittent failure of either the "On/Off" switch or the "Shock" switch can delay or prevent therapy, this correction was initiated to reduced a risk to health. However, you have not submitted a corrections and removal report to FDA for this correction.

We have reviewed your response and have concluded that it is inadequate because you do not plan to submit a corrections and removal report to FDA. Your response indicates that you do not believe that intermittent switch failure represents a risk to health. Further, you do not recognize that you have initiated a corrective action under Part 806 for this problem.

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 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 violations, or similar violations, 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. A follow up inspection will be required to assure that corrections are adequate.

Your response should be sent to: Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer; 22201 23rd Drive SE, Bothell, Washington 98021-4421. lf you have any questions about the content of this letter please contact: Lisa M. Elrand at (425) 483-4913 (tel.) or (425) 483-4760 (fax).

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/

Charles M. Breen
District Director