Medical devices.

13141W

Bayer Corp., Pittsburgh, June 17 (Detroit). FDA inspected the Bayer Healthcare LLC, Mishawaka, IN, facility April 15-20 to evaluate the adequacy of the company's activities related to the recall of Clinitek 50 urine chemistry analyzers. Significant deviations included failure to establish and maintain an adequate organizational structure to ensure the medical devices were designed and produced in accordance with requirements and failure to establish and maintain a Quality System. For example, non-conforming Clinitek 50 analyzers were released and distributed, and manufacturing changes were implemented without verification, validation or documentation. The warning letter also noted a failure to assure that personnel were adequately trained to perform assigned functions; failure to develop, conduct, control and monitor production processes to ensure the device conformed to specifications; and failure to have acceptance records documenting the dates activities were performed, the results, the signature of individual(s) conducting the activities and the equipment used. The agency pointed out that non-conforming Clinitek 50 analyzers were manufactured, released and distributed without detection of the defect, and an untrained operator was assigned to assemble Clinitek 50 analyzers. Bayer was also cited for failures to establish and maintain procedures for rework--and to document product rework and reevaluation activities--in the device history record; and failure to establish and maintain adequate procedures for implementing CAPA, which included requirements for analyzing processes, work operations, quality audit reports, quality records, service records, complaints and returned product. Lastly, FDA said the company lacked device history records to demonstrate that devices were manufactured according regulatory requirements. CAPA, C-H, QA/QS, Val

13142W

Thomas Boden, M.D., Cordis Corp., Warren, NJ, July 7 (New Jersey). FDA inspectors Peter Lenahan and Deborah Nixon conducted the Jan. 29-Feb. 26 investigation to determine if Boden's activities as sponsor for a clinical study complied with applicable FDA regulations. Inspectors noted among the deviations that Boden failed to ensure that investigators complied with the signed agreement, the investigational plan, the requirements of part 812 and other applicable FDA regulations, as well as other conditions of approval imposed by the reviewing IRB. According to the warning letter, amendments were made to the protocol; however, there was no documentation the amendments were approved by the study review panel. Furthermore, there was no Standard Operating Procedure to track the granting of waivers or protocol deviations or subsequent investigations; nor were there SOPs for the internal review and investigation of deficiencies identified through the field clinical monitoring reports. Additionally, Boden was cited for failure to monitor the progress of an investigation conducted under the IDE and failure to report that one of the co-principal investigators had his enrollment privileges suspended by his local IRB. And, a new principal investigator did not sign the Statement of Investigator until March 13, 2002, even though the enrollment was opened on Dec. 14, 2001. BiMo

13143W

Color Change Corp., Streamwood, IL, May 25 (Chicago). A Jan. 6-7 inspection determined the manufacturer of Liquid Crystal Temperature Strips failed to establish quality system, CAPA and complaint-handling procedures. CAPA, C-H, QC/QS

13144W

Thomas Croley, M.D., Central Florida Eye Institute, Ocala, FL, Jun. 14 (Florida and CDRH). FDA Florida inspectors Albertfiel Salvador and Brunilda Torres, and CDRH Safety Officer Contress Braxton, conducted the March 8-12 inspection to determine whether Croley's activities as a clinical investigator complied with applicable FDA regulations. Significant violations included failure to obtain adequate informed consent, and failure to conduct the study in accordance with the signed agreement, the investigational plan and applicable FDA regulations. For example, although the protocol only allowed for unilateral implants of the study product, Croley implanted subjects with the product in both eyes. Furthermore, for at least eight subjects, a waiver from the sponsor was not obtained prior to the implantation for the second study. Adverse event report forms were not completed and forwarded to the sponsor; and complete, accurate and timely case report forms were not submitted to the sponsor, the monitor and the reviewing IRB at regular intervals. The agency acknowledged receipt of a subsequent response letter but noted that specific steps to correct the deviations, and prevent future occurrences, were not outlined in the letter. AE, BiMo

13145W

Dental Manufacturing S.P.A., Badia Polesine, Italy, June 29 (CDRH). An April 13-15 inspection revealed the manufacturer of preformed, plastic denture teeth failed to establish and maintain procedures to control the design of the device and failed to maintain device history records. Moreover, the agency said the facility lacked a written quality policy. Design, QC/QS

13146W

Diamedix Corp., Miami, FL, June 3 (Florida). FDA inspector Victor Spanioli investigated the manufacturer of immunology and microbiology ELISA [Enzyme-Linked ImmunoSorbent Assay] IVD reagents and analyzers March 8-12 and determined Diamedix failed to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, and the company did not address numerous complaints. These included, for example, negative control indices and positive controls not meeting specifications for the product Syphilis Trepchek; an increase in false positives for Syphilis Trepchek; undissolved particles in the diluent causing the product Aptus probe to aspirate inconsistent volume of diluent; high recoveries for the negative control and low calibrator recovery for the product anti-Cardiolipin IgG; and high sample recoveries for the product ApoTek Lp(a). C-H, QC/QS

13147W

GF Health Products, Inc., Atlanta, GA, June 28 (Denver). Between April 5 and 29, FDA inspector Nathan Jornod investigated GF Health Products, Inc.'s manufacturing facility, known as Everest and Jennings LaBac Systems, located in Denver. The inspection determined the manufacturer of manual and powered wheelchairs did not have procedures in place to ensure that equipment was routinely calibrated, inspected, checked and maintained. Other significant deviations included failure to appoint a management representative; failure review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency; and failure to establish procedures for identifying training needs and to ensure that all personnel were adequately trained. Additionally, the manufacturer was cited for failure to document CAPA activities. For example, device defects and production quality deficiencies were not captured and documented; there was no evidence that quality data was documented; and daily inspection logs provided no reference to evaluation for corrective action. Lastly, the warning letter pointed out the firm had failed to analyze 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, and to employ appropriate statistical methodology to detect recurring quality problems. Cal, C-H, CAPA, QC/QS

13148W

John Sjoding Ab (K.A. Rasmussen a.s.), Hamar, Norway, June 29 (CDRH). Center for Devices' Office of Compliance inspected the company, a dental endosseous implants and attachments manufacturer, Feb. 9-12 and determined it failed to establish and maintain procedures to ensure that equipment was routinely calibrated, inspected, checked and maintained; and failed to document the equipment identification, calibration dates, the individual performing each calibration and the next calibration date. Moreover, the agency cited the manufacturer for failure to review, evaluate and investigate complaints; failure to make available documents meet document control requirements at all locations and to promptly remove all obsolete documents; and failure to have changes in documents reviewed and approved by an individual in the same function or organization that performed the original review and approval. Lastly, the company was hit with failure to establish procedures for identifying training needs and ensure that all personnel were trained to adequately perform their assigned responsibilities. FDA rejected a March 31 response letter because the response was not written in English. Cal, C-H, QC/QS

13149W

Keller Medical Specialties Products, Inc., Antioch, IL, June 3 (Chicago). FDA inspector James Plucinski conducted the Nov. 24-26, 2003, investigation of the manufacturer of blood pressure monitors, pulse oximeters and cardiac monitors. Quality System regulation deviations included that management with executive responsibility failed to ensure the quality policy was understood, implemented and maintained at all levels of the organization; failed to establish and maintain process control procedures; failed to establish quality audit procedures and conduct quality audits; and failed to establish and maintain procedures for implementing and documenting CAPA. Moreover, FDA said the manufacturer failed to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit, and failed to include or refer to the location of device specifications in its device master record. CAPA, QC/QS

13150W

Lumenis, Inc., Yokneam, Israel, June 14 (Denver). Feb. 17-27 and April 1 investigations by FDA at the company's Salt Lake City location determined the manufacturer of surgical laser systems and accessories for ophthalmic procedures neglected to validate processes for which results could not be fully verified by subsequent inspections or testing, and did not ensure the quality policy was implemented and maintained. Further, the agency noted that no procedures were maintained for implementing CAPA and for ensuring the devices were manufactured in accordance with device master records. FDA said Lumenis did not analyze all complaints using appropriate statistical methodology to detect recurring quality problems or trends. Evaluations of nonconforming product to determine the need for an investigation also were not being conducted. CAPA, C-H, QC/QS

13151W

Thomas Peters, M.D., Cottonwood, AZ, July 13 (Los Angeles). FDA inspector Diane Van Leeuwen conducted the April 12 inspection to determine if Peters's activities as a clinical investigator complied with applicable FDA regulations. Peters was cited for failure to adhere to the general and specific responsibilities of an investigator. Examples of this failure included that he implanted an investigational device into a subject who was not enrolled in the study and who did not sign the required informed consent form. The IRB initially approved the study on Feb. 27, 2003, which was nine months after the implantation into subject. During the inspection, Peters claimed to have used the device as a "custom device" and for "prescription and compassionate use," however, the agency noted that Peters had neither obtained appropriate approval for compassionate use nor did the custom device exemption apply to devices that he implanted. Additionally, Peters was hit with failure to maintain accurate, complete and current records. Copies of receipt and disposition of the investigational devices were missing from the study records, and postoperative follow-up x-ray films and reports were missing from the records. BiMo, MDR

13152W

John Brannon Smoot, M.D., Austin, TX, July 13 (Dallas). FDA inspector Brenda Stewart-Munoz conducted the March 8-12 investigation to determine if Smoot's activities as a clinical investigator complied with applicable FDA regulations. Stewart-Munoz noted that Smoot failed to adhere to informed consent requirements and maintain accurate, complete and current records evidencing informed consent. For example, one subject was implanted with the investigational device on July 15, 2003, but that subject did not sign the informed consent form until Aug. 1, 2003. Additionally, Smoot was cited for failure to conduct the study in accordance with the approved investigational plan and protocol; failure to report and obtain prior sponsor approval of protocol deviations; and failure to maintain accurate, current and complete records of a subject's case history and exposure to a device. According to the warning letter, the investigator administered an intraoperative regimen out of protocol and included subjects who did not meet the inclusion/exclusion criteria in the study. Moreover, there was no preoperative documentation for some of the subjects and some of the subject data scores were out of range or inaccurate. Some three- and six-month visit records, and x-ray documents, were missing as well. The agency rejected a subsequent March 25 response letter from Smoot, indicating in the warning letter that it did "not adequately address our concerns." BiMo

13153W

Spinal Concepts, Inc., Austin, TX, June 21 (Dallas). FDA inspected the manufacturer of the thoracolumbar systems and vertebral body replacement devices Feb. 5-6 and 9-12, and determined that complaint-handling procedures were not established. The manufacturer failed also to establish procedures for implementing CAPA that included requirements for verifying or validating that such action would be effective and would not adversely affect the finished device. Moreover, FDA said Spinal Concepts failed to develop production processes; failed to establish and maintain plans that described the design and development activities and define responsibility for implementation; failed to establish and maintain device design validation procedures that ensured that devices conformed to defined user needs and intended uses; and failed to include plans for testing of production units under actual or simulated-use conditions. CAPA, C-H, Design, Val

13154W

Steris Corp., Mentor, OH, June 15 (Chicago) During Jan. 13-Feb. 13 inspections of two Steris Isomedix Services, Libertyville, IL, facilities, FDA investigators determined that both contract sterilizers for medical devices were not in conformance with the Quality System regulations. Specifically, the agency noted failure to establish procedures for implementing CAPA; failure to establish control procedures necessary to ensure conformance to specifications, including documented instructions, SOPs, and methods that defined and controlled the manner of production; and failure to develop and monitor production processes. Additionally, no evaluations or investigations of nonconforming products and no quality audits were being conducted. The agency acknowledged receipt of an undated written response letter, but found it to be inadequate because "there was no documentation provided demonstrating that corrective actions have been implemented and are effective." CAPA, QC/QS