National = Genetics Institute Warning Letter

From: Subject: National Genetics Institute Warning Letter Date: Mon, 3 Mar 2008 10:00:14 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0026_01C87D15.60ADB080" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0026_01C87D15.60ADB080 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/archive/g5699d.htm National = Genetics Institute Warning Letter

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Department of Health and Human = Services	Public Health Service Food and Drug = Administration
	Los Angeles District 19701 Fairchild Irvine, CA=20 92612-2506 Telephone (949) 608-290 =

WARNING LETTER

W/L 14-06

CERTIFIED MAIL
RETURN RECEIPT REDUESTED=20

January 17, 2006

Michael A. Aicher
Chief Executive Officer
National Genetics=20 Institute
2440 S. Sepulveda Blvd., #235
Los Angeles, CA = 90064-1744

National Genetics Institute
2112 Cotner Avenue
Los Angeles, CA=20 90025-5714

Dear Mr. Aicher:

During inspections of National Genetics Institute (NGI), located at = 2440=20 Sepulveda Blvd, Los Angeles, California and 2112 Cotner Avenue, Los = Angeles,=20 California from August 22, 2005 to September 1, 2005, our investigators=20 determined that your firm manufacturesHuman Immunodeficiency Virus Type = 1=20 (HIV-1) nucleic acid tests (NAT) and Hepatitis C Virus (HCV) NAT, = performs donor=20 testing using those tests on donor samples received from source plasma=20 collection establishments and provides test results to those = establishments.=20 Accordingly, NGI is subject to regulation as both the manufacturer of = the HIV-1=20 NAT and HCV NAT manufactured at these locations, and as a testing = facility for=20 source plasma. Donor testing is an important step in source plasma=20 manufacture.

During the above stated inspections, violations applicable to your = device=20 manufacturing (Section 501(h) of the Federal Food, Drug, and Cosmetic = Act=20 (FD&C Act) and deviations from the applicable standards and = requirements of=20 Subchapter H, Part 820, Title 21, Code of Federal Regulations = (CFR)) and=20 source plasma manufacturing (deviations from the applicable standards = and=20 requirements of Subchapter F, Title 21, CFR) activities were documented. = Significant deviations observed during the inspections included, but are = not=20 limited to, the following:

1) You failed to validate computer software used as part of = production or=20 the quality system for its intended use according to an established = protocol=20 and/or failure to document the validation activities and results, and = failed=20 to make adequate provisions for monitoring the reliability, accuracy,=20 precision and performance of laboratory test procedures and = instruments [21=20 CFR 606.140(b), 606.140(c), 820.70(i)].

a) There are no data to demonstrate that databases created in=20 [redacted] computer software program, have been = properly=20 validated (installation qualification, operational qualification, and=20 performance qualification) as acceptable for their intended uses.=20 [Redacted] functions as the information management = tool used=20 to collect, organize, process, analyze, secure and maintain testing = data.=20 Specifically,

i) Twenty-one. (21) of the thirty-three (33) databases created in = [redacted] are identified as "pending" and have not = been=20 validated. These databases include: [redacted]

ii) In addition, validation of one (1) of the thirty-three (33)=20 [redacted] databases is identified as being = in-progress=20 [redacted] and validation of two (2) of the = thirty-three=20 (33) databases have been executed but not completed=20 [redacted]

b) There are no data to demonstrate that the quality = control/quality=20 assurance spreadsheets used for tracking and trending various quality = metrics=20 have been properly validated (installation qualification, operational=20 qualification, and performance qualification) and are performing as = intended.=20 Examples of these spreadsheets include: = [redacted]

2) You failed to establish and maintain written standard operating=20 procedures (SOPs) for steps in the testing of blood and blood = components=20 including acceptance activities such as: inspections, tests, or other=20 verification activities [21 CFR 606.100(b), 820.80(a)]. Your SOP K = 11.7=20 entitled "Procedure for Determining and Releasing Qualitative PCR = Results from=20 Multiplex Runs" does not reference all steps required to assure the = criteria=20 are met for release of PCR testing results and any deviations = associated with=20 the testing have been resolved. For example, instructions for = verifying the=20 information in the five fields in the [redacted] such = as=20 Internal Control, Lab Comments, Comments, Instructions and Temp Marker = are not=20 included in the SOP.

3) You failed to establish and maintain adequate procedures for = steps in=20 the testing of blood and blood components, including implementing = corrective=20 and preventive action, investigating the cause of non-conformances = relating to=20 product, processes and the quality system, and implementing adequate=20 laboratory control procedures [21 CFR 606.140, 820.100(a)(2)].=20 Specifically:

a) "Failed Run and Aberrant Control Monthly Summary" "Pre-PCR" = reports for=20 January and February 2005 revealed reporting discrepancies for the = total=20 number of failed runs, and total number of runs with aberrant = controls. The=20 numbers reported on the February 2005 summary for the previous month = (January=20 2005) did not agree with the numbers originally listed on the January = 2005=20 summary and there was no explanation for the discrepancy.

b) "Failed Run and Aberrant Control Monthly Summary" "Pre-PCR" = reports for=20 total numbers of aberrant controls for HIV and HCV testing in January, = and=20 April 2005 and total numbers of failed runs for HIV testing in = February and=20 April 2005 revealed reporting discrepancies. The numbers in the = "Failed Runs=20 and Aberrant Controls" database do not match the numbers that appear = on the=20 monthly summary reports for calculations performed on the percent = Averages,=20 percent Standard Deviations, and the [redacted].

c) "Failed Run and Aberrant Control Monthly Summary" "Pre-PCR" = reports from=20 September 2004 through April 2005 revealed reporting discrepancies in = that the=20 percent Average and percent Standard Deviation results did not change = from=20 month to month on the Aberrant Controls, Failed Run or Failed = Runs/Aberrant=20 Controls spreadsheets. The error was due to failure to use the current = rolling=20 12- month formula in the spreadsheet calculations.

d) In the February 2005 "Failed Run and Aberrant Control Monthly = Summary"=20 "Pre-PCR" report "Response Form" an error in the calculation of the = averages=20 and standard deviations was identified because a rolling 12 month = period was=20 not utilized for the calculation. A recalculation was performed and an = alert=20 level for HIV was identified. The "Response Form" states that the = primary=20 cause of the alert level is the introduction of a [redacted]=20 control in the National Genetic Institute (NGI) multiplex = standard in=20 which not all [redacted]. A thorough investigation = was not=20 documented and an investigation did not extend to previous failed runs = using=20 the [redacted]

4) You failed to establish and maintain process control procedures, = including documented instructions and written SOPs for steps in the = testing of=20 blood and blood components [21 CFR 606.100(b), 820.70(a)(1)].=20 Specifically:

a) There are no written procedures describing computer software=20 [redacted] functional requirements or descriptions of = functions and there is no computer manual. The database functions as = the=20 information management tool used to collect, organize, process, = analyze,=20 secure and maintain testing data.

b) There is no written procedure defining the deviation types = currently=20 existing in the deviation report database in = [redacted].=20 Specifically, some of the field selections for deviation types defined = in SOP=20 B 4 "Procedure for Reporting Deviations" (Revision 8) (e.g. Procedural = Non-Compliance, Technician Error/Laboratory Accident, Other) and those = appearing in the deviation report database drop-down list fields (e.g. = General, Process, Documentation Omission, Non-Deviation, = Error-Technician) do=20 not correlate. Furthermore, you have not documented the changes made = to the=20 drop down list tables for the deviation report database.

c) There are no established written standard operating procedures = for=20 entering "Lab Comments" into [redacted].Deviation = Report (DR)=20 2005-0303 was generated for specimen #[redacted] and=20 [redacted] and matrix [redacted] due = to=20 possible sample position mix up on a [redacted] = sample matrix=20 at positions [redacted] and = [redacted].=20 There are no "Lab Comments" entered in [redacted] to = notify=20 the review analysts of this deviation.

d) SOP B 17.4 "Procedure For Investigating Failed Runs And Runs = With=20 Aberrant Controls", approved on February 17, 2003, was not followed in = that=20 you did not document the results for six of the seven investigation = criteria=20 listed in this procedure for Accessioning number (AC) #05-34249, = 05-34238,=20 04-28115, 04- 29101, 04-28346, 05-37738, 05-38477, 05-38476, and = 05-38393.=20 This procedure states "If a run fails to meet the acceptance criteria = for any=20 reason other than the failure of a single control, further = investigation . .=20 .takes place."

e) SOP B 6.5, which outlines the NGI auditing program, does not = include=20 directives for reviewing failed runs and aberrant control. However, = reports to=20 assure these investigations are being performed and documented are = required in=20 SOP B 17.4"Procedure for Investigating Failed Runs and Runs with = Aberrant=20 Controls.

We also note that you have failed to establish an adequate system for = authorizing, granting, and rescinding computer access to functions in = the=20 [redacted] and adequate computer security provisions to = assure=20 data integrity. Current users do not use appropriate access such as = passwords=20 and user-id and personnel who have changed jobs still have access to the = system.

The deviations identified above are not intended to be an = all-inclusive list=20 of deficiencies at your establishment. It is your responsibility as = management=20 to assure compliance with all requirements of the federal regulations = and the=20 standards in your license.

Federal agencies are advised of the issuance of all Warning Letters=20 pertaining to medical devices so that they may take this information = into=20 account when considering the award of contracts.

We acknowledge receipt of your written response dated October 14, = 2005, which=20 addresses the inspectional observations on the Form FDA 483, issued at = the end=20 of the inspection to management at the Sepulveda Boulevard facility. We = have=20 completed our review and although some corrective actions have been = implemented,=20 your responses are inadequate in a number of respects and for the = following=20 reasons, do not adequately address our concerns. The items numbered = below=20 correspond to the observations listed on the Form FDA 483:

1) Responses to Observations l, 2, 4, 5 and 6 are considered = inadequate in=20 that:

a) In your response, you propose delaying validation of some = systems=20 until May 2006. We recommend that you re-evaluate your timeframe and = implement the corrective action as soon as = possible.

b) Several pertinent documents which were referenced in your = response were=20 not submitted to the FDA including:

i) NGI SOP L22 "Procedure for Using [redacted]=20 Applications"
ii) Plan for completion of "retrospective" = validation of [redacted]
iii) Change control = documents=20 that address the issues associated with the = database.

2) Responses to Observations 3, 13 and 14 are considered inadequate = because=20 several pertinent documents which were referenced in your response = were not=20 submitted to the FDA including:

i) Spreadsheets used for Quality Control and Quality Assurance = including=20 tracking and trending which were included in a list of items for=20 validation.
ii) Documentation of your investigation of the failed = run and=20 aberrant control report for February 2005.
iii) NGI SOP K11 = "Procedure=20 for the Data Entry of Qualitative Samples and Worklist = Generation".
iv)=20 NGI SOP K30 "Procedure for Using pool Results to Determine the = Status of=20 Component Samples".

3) Responses to Observations 9, 10, 11 are considered inadequate = because=20 documented investigations were not initiated to address the violations = and=20 there is no proposal for corrective actions.

4) Responses to Observations 7, 12, 16, 17 and 20A are considered=20 inadequate because certain aspects of the violations were not = addressed in=20 your response including:

i) The status of final test results of nine samples which were = included=20 in testing that either had a failed run or aberrant controls, since = SOP B=20 17.4 "Procedure for investigating Failed Runs and Runs with Aberrant = Controls" was not being followed.
ii) A plan to address the = review of=20 investigations of failed run and aberrant controls in your newly = expanded=20 audit program.
iii) A plan to include review of fields in the=20 [redacted] including Internal controls, Lab = comments,=20 Comments, Instructions and Temp Marker prior to release of test = results, in=20 your revised SOP K11 "Procedure for the Data Entry of Qualitative = Samples=20 and Worklist Generation".

5) Responses to Observations 18 and 19 appear to be adequate, but = will=20 require a review of SOP B6 "Quality Audit Program", SOP B7 "Procedure = for=20 Generating Trend and Summary Reports for Management Review" and SOP = K27=20 "Procedure for Reviewing and Releasing Raw Data Images and Run Sheets = from the=20 Post-PCR Laboratory" during your next inspection.

You should take prompt action to correct these deviations. Failure to = promptly correct these deviations may result in regulatory action being=20 initiated by the Food and Drug Administration without further notice . = These=20 actions include, but are not limited to, seizure, injunction, license=20 suspension, and/or revocation.

Please notify this office within fifteen (15) working days of receipt = of this=20 letter of the specific steps you have taken to correct the noted = violations=20 including an explanation of each step being taken to identify and = prevent the=20 recurrence of similar violations. If corrective action cannot be = completed=20 within (15) working days, state the reason for the delay and the time = within=20 which the corrections will be completed.

If you have any questions regarding this letter, please contact Ms. = Maiiza M.=20 Jafary, Compliance Officer at 949-608-2977.

Your written reply should be addressed to:

Pamela B. Schweikert
Director, Compliance Branch
Food and = Drug=20 Administration
19701 Fairchild
Irvine, CA = 92612-2446

Sincerely,

/S/

Alonza E. Cruse
District Director

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FDA/Freedom=20 of Information

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