Inspections, Compliance, Enforcement, and Criminal Investigations
Perkins Electronics Company 02-Nov-06
Department of Health and Human Services
Public Health Service
November 2, 2006
Ref: 2007-DAL WL-01
RETURNED RECEIPT REQUESTED
Mr. Steven K. Plaugher, General Manager
Perkins Electronics Company
1510 North Washington Avenue
Dallas, Texas 75204
Dear Mr, Plaugher:
During an inspection of your firm located at the above referenced address on September 5 through 8,11,12 and 25, 2006, the United States Food and Drug Administration (FDA) determined that your firm manufactures video enhancement units (Fluoro Fade and Spirit), video up scan/down scan converters, Medical (MDVD) video recorders/players, video matrix controllers (video switching and distribution), and optical isolation amplifiers, for video processing of medical images (enhancement, display, storage, and distribution of medical images). Under section 2(31(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 conformance 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.
These violation include, but are not limited to the following:
1. Failure to establish and maintain procedures for validating the device design to ensure that the device conforms to users needs and intended uses, design testing is conducted under actual or simulated use conditions, risk analysis is conducted, and design testing results are maintained, as required by 21 CFR §820.30(g). FIDA-483 item 1(b), 2, 3, 4, 5. A review of your firm's design control records and procedures revealed that your firm's design testing process was not robust to detect product performance issues during your design development phase in order to reduce the number of post production design changes in the form of product upgrades. The MDVD,Fluoro Fade, and Spirit devices received the most number of hardware/software upgrades after they were released for commercial distribution as reflected in your firm's service log. For example:
a. Three consecutive engineering changes were made to the main PCB board of the Model 2165 Fluoro Fade on 2/15/05, 4/25/05, and 7/18/05, to correct a recurring hardware timing problem in the [redacted] clock settings and terminations which caused jumping medical images (e.g. jumping [redacted] video output). The testing protocol and results of these engineering changes, including testing under actual or simulated conditions, were not documented. During the second engineering change of 4/25/05, your firm reworked all remaining PCB boards in your inventory to the design revision in ECO 2165_0000_050425 but did not investigate if other devices currently in distribution could potentially still have the same timing problem. On 7/18/05 your engineer reported the same timing problem and made further adjustments.
b. On 1/29/03 your firm changed the software [redacted] codes of the Spirit Model 2167 device to address an intermittent problem with the lateral board displaying a red LED error. From 1/31/03 through 12/3/03, your firm revised the device's [redacted]codes four times in four consecutive software design changes to correct a recurring timing problem but did not document the testing protocol and results of these software changes, including testing under actual or simulated conditions.
c. Design verification and validation testing to introduce the PKP-2431 MDVD recorder (a device to record and playback diagnostic medical images) was not effective. From 10/19/05 through 7/14/06, sixteen (16) devices were returned to our firm for hardware/software upgrades which primarily involved the [redacted] PCB board and [redacted] PCB board. These upgrades were intended to correct known product issues with intermittent device lockups, not recording medical images, or missing recordings.
d. An unresolved design discrepancy was noted at the completion of your design validation of the PKP-02721 Compact Scan Converter that could potentially result in loss of medical images. Your firm did not document whether the problem can be detected and prevented during initial product installation at user sites, and your risk analysis results for this design discrepancy.
2. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required 21 CFR § 820.30(h). FDA-483 Item 9. For example:
a. Not all product returns (PKP-2966 Fluoro Fade) received the latest design revision of the main PCB board to correct known product issues. Some of the returned Fluoro Fade Model 2166 devices were upgraded to the latest main PCB board revision of [redacted] and some were upgraded to the older main PCB board revision of [redacted]. There was no explanation of what happened in the product reports (PR) for those devices.
b. Document of design changes for the Model 2166 Fluoro Fade device has not been established. Although the Model 2165 and Model 2166 Fluoro Fade devices share the same main PCB board containing the same design changes, your firm has neither created a separate design change document for Model 2166 nor updated the existing design change document MAA [redacted] of Model 2165 to include Model 2166.
c. Your firm has not defined written instructions or written procedures to describe and identify which design change versions are approved versions releasable to production for commercial distribution.
3. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR § 820.30(i). FDA-483 Item 7 and 8. For example, although your firm has an engineering change order (ECO) procedure (PRC 00020.202, dated 2/18/03) that describes the document structure and who is authorized to generate and sign ECO, this ECO procedure is not adequate in that:
a. It does not have defined, documented, and approved specific design inputs and sources of design inputs that lead to design changes (e.g. user reports, feedbacks from [redacted] internal engineering evaluation of a prototype unit, etc.).
b. It does not have defined and documented procedures for how design changes are to be verified through performance testing or validated through user testing, and the testing results of a design change are reviewed, approved for release to production, documented, and filed in the design, history file.
c. The three engineering change orders generated to correct a recurring clock timing problem that caused jumping medical images in Fluoro Fade Model 2165 does not document approval date(s) and the signature(s) of individual(s) approving these engineering change orders for release to production.
4. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address use of the device, including the needs of the user and patient, as required by 21 CFR § 820.30(c). FDA-483 item 6. For example:
a. Your firm's design input document entitled "Spirit Unit - Unit Requirement Specification," dated 11/5/02, is incomplete in that it lacks a clear explanation of the Spirit's intended uses (what its image filtering functions are supposed to do to enhance the quality of medical images) and a description and/or an illustration of the system diagram interface connecting your Spirit device to other network imaging devices used by [redacted]
b. The design input document states to use the [redacted] simulator to send a test digital video input signal to the Spirit device. However, your firm stopped using the [redacted] simulator and instead used another simulator called the [redacted] simulator. This change was not approved and documented in the design input document.
c. The design input document was revised several times from 7/18/02 through 3/12/03 without documenting a description of each change.
5. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100(a). FDA-483 Item 10 and 12 . For example:
a. Your firm has not analyzed your service log, problem reports, or other quality sources to verify the effectiveness of each design change and documented the results of your firm's analysis.
b. Problem reports (complaint forms) did not always document the reason, nor reference any engineering change order (ECO) to explain why each returned device needed to have an upgrade.
c. Root cause investigation of product defect(s) was not always conducted and documented for each returned device needing a hardware or a software upgrade. For example , problem report (PR) 715 and 739, dated 1/3/06 and 3/23/06, documented "error - Spirit's processing is not available, software needs to be upgraded . . . ., upgraded [redacted] from version [redacted] to [redacted]. Your firm did not explain and document if other Spirit devices currently in distribution could potentially still have the same type of error.
d. Your firm has no procedures for analysis of internal non-conformances recorded in your firm's [redacted] database on a routine basis from 9/05 through 9/06.
6. Failure to establish and maintain acceptance procedures for inspections, tests, or verification activities to ensure that specified requirements for in-process product are met, as required by 21 CFR § 820.80(c). FDA-483 Item 11. For example:
Your firm's [redacted] 2006 management review identified that (49) of the [redacted] chips failed at the PCB board testing level. (26) of the (43) failed chips were traced to Job Control Number (JCN) EA 62, dated 3/6/06. Your firm did not document its reject of the (26) failed [redacted] chips in the PCB board assembly record for JCN EA 62, and the PCB boards were used in the final assembly of the compact scan converters.
7. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR § 826.198(a). FDA-483 Item 15. For example:
a. Fourteen (14) problem reports recorded product upgrades but lacked a description for each upgrade to explain whether it was initiated to correct a product defect or to add a new product feature.
b. Seven (7) problem reports for the MDVD recorders documented that seven (7) MDVD recorders were returned to your firm for repair buSt lacked a description of why these devices malfunctioned and their and their corrective action.
8. Failure to establish and maintain procedures to adequately control environmental conditions to prevent an adverse effect on product quality, periodically inspect environmental control system(s), and document inspection activities to verify that the system, including the necessary equipment, is adequate and functioning properly, as required by 21 CFR § 820.70(c). FDA-483 Item 13 and 14. For example:
a. Your firm's Director of Operations and Manufacturing stated that your electrostatic discharge (ES[3) protection system and grounding was. installed fifteen (95) years ago. At the time of the inspection, your firm had no ESD blueprint (layout) to show what manufacturing areas are ESD protected and has not tested the ESD system since then. ESD could cause short term or long term damage to electronic components.
b. The FDA inspection disclosed three large spots of water stains on the ceiling of the storage room that houses finished devices and components and a bucket of water located directly under one of those spots. It had rained the day before the FDA began to the inspection. Water leaks could potential adverse effect on product quality.
9. Failure to establish and maintain procedures for quality audits and conduct effective audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness, of quality system, as required by 21 CFR § 820.22. FDA-483 Item 1 through16. For example:
Your firm's audit questionnaire was general in nature and simply copied or referenced the general ISO requirements without establishing an audit plan that identifies a specific product, specific areas of the quality system, specific records and procedures, and specific questions to be asked of your employees during each [redacted] or [redacted] audit.
Your devices are also misbranded under Section 502(t)(2) of the Act, 29 U.S.C. § 352(t)(2), in that your firm failed to furnish any material or information respecting device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. For example, your firm failed to establish and maintain adequate written MDR procedures, as required by 21 CFR § 803.17, and maintain documentation and record keeping requirements for MDR event files, as required by 21 CFR §803.18. FDA-483 Item 16.
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 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, premarket approval applications for Class III devices to which the QS 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 these corrections. If the 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.
Your response should be sent to Thao Ta, Compliance Officer, DAL.-DO, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If' you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
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 violations regulations administered by FDA. The specific violations noted in this letter and in the 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 causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Michael A. Chappell
Dallas District Director