Inspections, Compliance, Enforcement, and Criminal Investigations
Pace Tech, Inc. 29-Apr-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
April 29, 2005
Ilhan M. Bilgutay, President
Pace Tech, Inc.
510 N. Garden Avenue
Clearwater, Florida 33755-4126
Dear Mr. Bilgutay:
During an inspection of your establishment located in Clearwater, Florida on January 24-26, 2005, a United States Food and Drug Administration (FDA) investigator determined that your establishment manufactures stationary and portable patient monitors (Class 2). These products are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)].
The investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. 351 (h)] of the Act.
The investigator noted the following violations of the QS regulations:
1. Your firm fails to have sufficient personnel with the necessary education, background, training, and experience to assure that the requirements of the QS Regulation are correctly performed, as required by 21 CFR 820.25. Your firm lacks qualified personnel and resources to institute an adequate quality control program. Both your production and quality control managers left the firm and personnel who assumed responsibility for production and quality control functions are not adequately trained in the Quality System (QS) Regulation or Medical Device Reporting (MDR) (FDA 483, Item #1).
Your firm's response dated March 18, 2005 is inadequate because the investigator determined during the inspection that your firm was operating short-handed then, and the rehiring of one individual will not address the lack of trained personnel to production, quality and regulatory affairs. Secondly, your response states that all test equipment is in the process of being calibrated and documented . No documentation was provided showing corrective actions that have been effected.
2. Each manufacturer shall establish 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 . Quality audits shall be conducted by individuals who do not have direct responsibility for the matters and shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented as required by 21 CFR 820.22 . internal quality audits conducted by your firm failed to verify that the quality system was effective in fulfilling quality system objectives (FDA 483, Item #2).
Your response dated March 18, 2005 is inadequate because it fails to provide evidence that a quality audit was conducted and fails to identify the areas that were audited.
3. Your firm fails to implement and maintain corrective and preventive action (CAPA) procedures that include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR 820.1 00(a)(1). First, your firm fails to analyze and document in-process rejects according to defect codes over time in order to determine the need for corrective and preventive action. Second, your firm's analysis of complaints/repairs (trend analysis) last done in 2003 uses defect codes which fail to identify a failure mode, e.g., 23 of 88 repairs were coded "monitor opened by end user", 12 of 88 repairs were coded "old manifold", 19 of 88 repairs were coded "unable to find problem", 9 of 88 repairs were coded "old connector", 8 of 88 repairs were coded "incorrectly repaired by end user", 7 of 88 repairs were coded "old battery", and 5 of 88 repairs were coded "faulty connector". In addition, review of compiaints/repairs received in 2004 found complaints related to failures of main boards, EPROMS, pneumatics, broken fuse holders, SpO2 not working and recalibration of blood pressure and temperature revealed there are no defect codes for these types of failures . Third, your firm's trend analysis which is supposed to be done twice a year has not been done since 2003 (FDA 483, Item #7).
Your response dated March 18, 2005 to FDA 483, item #7A is inadequate because it failed to provide a copy of revised procedure QOP-83-01 addressing the revisions made with regard to non-conforming product. There is no evidence provided that trend analysis has been established and will be documented or of the performance of CAPA.
Your response to FDA 483, Item #7B appears to be adequate, however, blank copies of forms were provided and will require assessment during the next inspection to assure the forms are used and effective in resolving the issues related to complaints.
Your response to Item #7C is inadequate because there is no documentation or evidence that this procedure is established and effective.
4. Your firm fails to establish and implement corrective and preventive action (CAPA) procedures that include_requirements for identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3) . Your firm has had units returned for recalibration even though it is known that patient monitors will drift out of calibration over time. The Model 911 Operator's Manual includes a requirement that the MiniPack 911 should be checked occasionally for proper calibration of NIBP using the stated procedure and, if consistent discrepancies persist to return the device to Pace Tech to perform the calibration. No other calibration is mentioned and the Operator's Manual fails to state that patient monitors will drift out of calibration and, therefore, calibration must be done to assure accuracy. This also applies to the Operator's Manuals for the Model 400114100 monitors (FDA 483, Item #6).
Your response dated March 18, 2005 addressing FDA 483, Item #6 is inadequate because there is no evidence of updates to service manuals and documentation that will be used to track calibration intervals.
5. All activities required by 21 CFR 820.100 must be verified or validated to ensure that such action is effective and does not adversely affect finished devices, and the results of these activities shall be documented as required by 21 CFR 820.100(a)(4) and (b). Your firm's CAPA procedures fail to document how analysis is done and fails to require verification/validation that CAPA does not adversely affect finished devices (FDA 483, Item #8).
Your response dated March 18, 2005 addressing FDA 483, iiem #8 is inadequate because QOP 85-04 fails to address how complaint investigations, design control and CAPA will be established to address all forms of reports of non-conformance. The QOP also fails to address validation of new designs made as a result of complaints and other forms of quality reports.
6. Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct adequate process validation in that soldering (baking) validation is not documented and there is no validation of software used in the complaint repair system to document previous repairs to devices.
Your response dated March 18, 2005 addressing FDA 483, Item #12A & B is inadequate because there is no evidence of a validation protocol or actions that have been taken to date for both your soldering process and changes made to software.
7. Each manufacturer shall maintain complaint files and, establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that all complaints are processed in a uniform and timely manner as required by 21 CFR 820.198(a). Your firnn fails to document complaints unless the device is under warranty or the device is actually sent in for repair; and your firm fails to process complaints in a uniform and timely manner since repairs received in 2004 were only given four dates (1/29, 3/25, 8/10, and 11/18/2004) (FDA 483, Item #s 3 & 5).
Your response dated March 18, 2005 addressing FDA 483, Item #3 appears adequate, however, no evidence of the establishment of the revised Complaint procedure, its current use or any documentation of complaints that have been received was provided. Your response addressing FDA-483, Item #5 fails to provide evidence of your commitment to document all complaints including devices returned for service and the investigation to the root cause.
8. Your firm fails to properly investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications. Such complaints shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary as required by 21 CFR 820 .198(c). "Not in code" complaints concerning NIBP (two complaints dated 11/18/2004), main board complaints, EPROM complaints, cuff keeps inflating complaints, leaking pneumatic complaints, and cord defective complaints were not properly investigated by your firm to determine the root cause or take corrective and preventive action (FDA 483, Item #4).
Your response dated March 18, 2005 addressing FDA 483, Item #4 is inadequate because your revised QOP fails to include how Design Controls will be implemented to address all changes made and validation/verification is not addressed to ensure that CAPA is effective.
9. Your firm fails to document and review environmental control procedures as required by 21 CFR 820.70(c) . Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. The following observations reveal that environmental controls are not properly documented or reviewed: (a) there is no assurance that employees are adequately grounded by using a single ankle strap since employees do not always have the strap in contact with skin or a grounding mat, (b) there is no grounding mat on the floor in the pc board testing area, (c) the grounding mat next to the Pick & Place/Solder machine is not properly grounded, (d) grounding mats are not tested pursuant to a specified schedule, (e) paper is placed inside pc board anti-static bags, (f) two totes of power boards were observed not placed in anti-static bags, one tote of main boards was stored in open anti-static bags, (g) an employee was observed touching pc boards without wearing a wrist or ankle strap, (h) there is no written Electrostatic Discharge (ESD) procedure, and (i) testing of ankle straps was not documented from 10/22/2004 to 1/21/2005 (after pre-notification of this FDA inspection) (21 CFR 820 .70(c) (FDA 483, Item #9).
Your response dated March 18, 2005 addressing FDA 483, Item #9 appears to be adequate . Your corrective actions will be addressed during the next inspection of your firm.
10. Your firm fails to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants as required by 21 CFR 820.50(a). Incoming (bare) pc boards are not sufficiently verified by test stamp upon receipt. Only the first article test is completed on some boards (FDA 483, Item #13).
Your response dated March 18, 2005, addressing FDA 483, Item #13 is inadequate because there is no evidence of documentation to certify that vendors meet all of your requirements.
11. Your firm fails to have and document calibration procedures that include specific directions and limits for accuracy and precision, equipment identification, calibration dates, the individual performing each calibration, and the next calibration date, as required by 21 CFR 820.72(b) . There is no calibration procedure for test equipment except for multimeters ; and there is no documentation of calibration dates for inspection, measurement, and test equipment (FDA 483, Item #s 10 & 11).
Your response dated March 18, 2005 addressing FDA 483, Item #s 10 & 11 is inadequate because you fail to provide any evidence other than the procedure for the ESD test device 3M Charge Guard Model 716 of corrective actions taken and their effectiveness.
12. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall include risk analysis, where appropriate as required by 21 CFR 820 .30(g). There was no risk analysis conducted as part of design change from Model 4000 to Model 4000 CL done in 1998 to 1999 (FDA 483, Item #14).
Your response dated March 18, 2005, addressing FDA 483, Item #14 may be adequate and will be assessed during the next inspection of your firm. You should take prompt action to correct these deviations . Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Gove'rnments will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District