Siemens = Medical Solutions USA, Inc., Warning Letter

From: Subject: Siemens Medical Solutions USA, Inc., Warning Letter Date: Mon, 3 Mar 2008 11:03:00 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_006E_01C87D1E.24F5F990" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_006E_01C87D1E.24F5F990 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6655c.htm Siemens = Medical Solutions USA, Inc., Warning Letter

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Department of Health and Human Services

Public Health Service
Food and Drug = Administration

New Orleans District
404 BNA Drive
Building 200 - Suite = 500=20
Nashville, TN 37217

Telephone: (615) 366-7801
FAX: (615)=20 366-7802

January 28, 2008

WARNING LETTER NO. 2008-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Michael Reitermann, President
Siemens Medical Solutions USA, Inc. =
Molecular Imaging Division
2501 North Barrington Drive =
Hoffman=20 Estates, Illinois 60192

Dear Mr. Reitermann:

During an inspection of your firm, located at 810 Innovation Drive,=20 Knoxville, Tennessee on July 16, 2007 through August 7, 2007, = investigator(s)=20 from the United States Food and Drug Administration (FDA) determined = your firm=20 manufactures molecular imaging diagnostic equipment device(s). Under = Section=20 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United = States=20 Code (21 USC) 321(h)], these products are devices because they are = intended for=20 use in the diagnosis of disease or other conditions or in the cure, = mitigation,=20 treatment, or prevention of disease, or are intended to affect the = structure or=20 function of the body.

This inspection revealed these devices are adulterated within the = meaning of=20 Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or = the=20 facilities or controls used for, their manufacture, packing, storage, or = installation are not in conformity with the Current Good Manufacturing = Practice=20 (CGMP) requirements of the Quality System (QS) regulation found at Title = 21,=20 Code of Federal Regulations, Part 820 (21 CFR = 820). We=20 received a response letter from Vice-President of Regulatory Affairs and = Quality=20 Assurance, Ron Nolte and you, dated August 20, 2007, concerning our=20 investigator's observations noted on Form FDA 483, List of Inspectional=20 Observations, issued to Mr. Nolte. We have reviewed your response and = concluded=20 it is inadequate in relation to each of the noted violations, which = include, but=20 are not limited to, the following:

1. Your firm failed to establish and maintain adequate procedures = to=20 control design validation, including software validation and risk = analysis,=20 where appropriate, as required by 21 CFR 820.30(g). For example:

a. Because you failed to follow your procedure, the acceptance = criteria=20 were not complete prior to the performance of validation activities. = Specifically, [redacted] for ECAT scanners = introduced an=20 error in the scan start time used in the decay correction algorithm. = This=20 error was most pronounced in the TTTT/EEEE mode which was not tested = during=20 the validation of the software update.

b. Risk analysis is incomplete. The risk analysis for the hazard = of=20 linking PET/CT scans to the incorrect patient was performed after a = June=20 2006 incident. The risk analysis has not been re-assessed/updated = for=20 increased probability given the three subsequent incidents. Your = firm's=20 Standard Operating Procedure directs risk analysis be reviewed and = updated=20 upon receipt of safety-related complaints. However, no risk analysis = was=20 performed for complaints related to incorrect normalization values = in=20 [redacted] PET/CT scanners. Complaint 07-0215, = received on=20 or about February 28, 2007 concerning incorrect normalization = values, states=20 the complaint review board directed a risk analysis be performed. = Two=20 subsequent complaints were received but no risk analyses were = performed.=20

You did not provide the newly-created acceptance criteria for = future=20 revisions to the software nor documentation to substantiate your claim = of=20 reevaluation of the hazard analysis for ECAT systems. You did not = provide=20 copies of the procedure [redacted]. Also, the = response=20 indicates the two risk analyses were performed, and complaint and risk = analysis procedures were revised, but copies were not provided. Please = provide=20 these documents for our review.

2. Your firm failed to establish and maintain adequate procedures = for=20 implementing corrective and preventive action (CAPA) to ensure the = analyzing=20 of sources of quality data to identify existing and potential causes = of=20 nonconforming product, or other quality problems and employ = appropriate=20 statistical methodology, where necessary, to detect recurring quality=20 problems, as required by 21 CFR 820.100(a)(1). For example, your = firm's CAPA=20 procedures inadequately identify quality data to be analyzed or the=20 statistical methods to be used to analyze quality data.

You did not submit copies of the revised CAPA and new trending = procedures=20 for review. You also did not provide evidence of implementation of = these=20 procedures. Your response should address preventive actions to ensure=20 identified sources and statistics chosen are capturing the necessary=20 information to proactively address quality problems and/or issues. =

3. Your firm failed to establish and maintain adequate procedures = are=20 conducted which assure the investigation of the cause of = nonconformities=20 relating to product, processes, and the quality system, as required by = 21 CFR=20 820.100(a)(2). For example, a formal process does not exist to = document=20 investigation into returned parts.

You did not provide copies = of the=20 revised CAPA and complaint procedures nor the eCAPA [redacted] = process for returned parts for our review. Please provide = evidence of=20 implementation of the corrective measures taken.

4. Your firm failed to establish and maintain adequate procedures = to=20 identify action(s) needed to correct and prevent recurrence of = nonconforming=20 product and other quality problems, as required by 21 CFR = 820.100(a)(3). For=20 example:

a. At least four complaints were received concerning PET/CT scans = linked=20 to the wrong patient. Complaint PC0000295 was entered into your = firm's=20 complaint system on September 27, 2005; complaint PC0000636 was = entered on=20 June 12, 2006; complaint 070098 was reported to your firm on January = 30,=20 2007; and, complaint 07-0663 was reported to your firm on June 11, = 2007. The=20 software bug has been corrected in devices distributed since July = 2006, but=20 neither a software fix nor user notification has been distributed to = customers who have devices received prior to July 2006.

b. Your firm's current CAPA procedures inadequately address = preventive=20 activities to be considered.

c. The corrective and preventive actions for ECAT PET scanner=20 malfunctions caused by software deficiencies and the required = Medical Device=20 Reporting submissions did not include documented preventive actions=20 considerations.

Regarding item a, you did not provide a copy of the reassessment of = the=20 risk analysis which was performed. Since your firm has two different = risk=20 mitigations for the same problem, you should provide documentation = showing=20 both choices (software fix and user notification) address the problem = and are=20 compliant with your current risk management procedures. You did not = provide=20 the finalized copies of the user notification letter, risk management=20 procedure and complaint handling procedure. You also should provide = the=20 training documentation which assures affected personnel have been = trained on=20 the revised procedures and/or practices.

Regarding item b, you did not provide a copy of the revised CAPA = procedure=20 [redacted] for our review.
Regarding item c, you = did not=20 provide the newly-created acceptance criteria for future revisions to = the=20 software, and provide documentation to substantiate your claim of = reevaluation=20 of the hazard analysis for ECAT systems.

5. Failure to establish and maintain adequate complaint procedures = for=20 receiving, reviewing, and evaluating complaints, as required by 21 CFR = 820.198(a). For example:

a. Complaints are not handled in a uniform and timely manner as = specified=20 by your procedures. Specifically, there are instances where the = assignee of=20 a complaint did not notify the complaint coordinator and indicated = an=20 expected date of investigation completion after the 60 day due date = which is=20 specified by the complaint handling procedures.

b. There was no documentation to indicate complainants were = notified and=20 informed of complaint resolutions after the complaint was closed, as = required by current complaint handling procedures.

c. The complaint handling procedures do not address how multiple=20 complaints regarding the same defect will be handled. Multiple = complaints=20 were observed during the inspection concerning "Main User Interface=20 Crashes".

d. A complaint form indicates Siemens was notified on June 15, = 2006, of=20 asymmetry in a whole body scan. This incident was not entered into = the=20 complaint handling system until March 21, 2007, after receipt of = subsequent=20 complaints of asymmetry in brain scans.

You did not provide the revised complaint handling procedure, the=20 newly-created trending procedure, the revised procedure=20 [redacted] and the training records of the affected=20 personnel.

6. Your firm failed to establish and maintain adequate procedures = to=20 control documents and ensure all obsolete documents are promptly = removed from=20 use or otherwise prevented from unintended use, as required by 21 CFR=20 820.40(a). For example, approximately nine observations were made of = complaint=20 data being recorded on obsolete versions of complaint forms. = Specifically,=20 Complaint 07-0341 was observed to document a "Date of Event" as March = 17,=20 2007, and [redacted] as March 17, 2007; however, the revision date of = the form=20 was [redacted] introduced in 2004. A list of complaint form revisions = was=20 provided to the investigators by firm management, which indicated five = revisions during 2005 and 2006.

You did not provide the training documentation, the revised = complaint=20 handling procedure and the documentation pertaining to the = newly-implemented=20 electronic device and your electronic complaint system. =

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in = regulatory=20 action without further notice, including seizure, injunction, and/or = civil money=20 penalties. Federal agencies are advised of the issuance of all warning = letters=20 about devices so they may take this information into account when = considering=20 the award of contracts. Additionally, premarket approval applications = for Class=20 III devices to which the QS regulation deviations are reasonably related = will=20 not be approved until the violations have been corrected. Requests for=20 Certificates to Foreign Governments will not be granted until the = violations=20 related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days = from=20 the date you receive this letter of the specific steps you have taken to = correct=20 the noted violations, including an explanation of how you plan to = prevent these=20 violations, or similar violations, from reoccurring. Include = documentation of=20 the corrective action you have taken. If your planned corrections will = occur=20 over time, please include a timetable for implementation of those = corrections.=20 If corrective action cannot be completed within 15 working days, state = the=20 reason for the delay and the time within which the corrections will be=20 completed.

Your response should be sent to Kari L. Batey, Compliance Officer, = U.S. Food=20 and Drug Administration at the above address. If you have any questions = about=20 the content of this letter, please contact Ms. Batey at (615) 366-7808. =

This letter is not intended to be an all-inclusive list of violations = at your=20 facility. It is your responsibility to ensure compliance with applicable = laws=20 and regulations administered by FDA.

The specific violations noted in this letter and in the List of = Observations,=20 Form FDA 483, issued at the closeout of the inspection, may be = symptomatic of=20 serious problems in your firm's manufacturing and quality assurance = systems. You=20 should investigate and determine the causes of the violations, and take = prompt=20 actions to correct the violations and bring your products into = compliance.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans=20 District

Enclosures: FDA 483 dated August 7 and 8, 2007

cc: Kenneth F. Baker; Vice President of Operation
Siemens Medical = Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN = 37932-2571

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FDA/Freedom=20 of Information

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