Failure to review, evaluate and investigate complaints involving the possible failure of a device to meet any of its performance specifications; failure to thoroughly evaluate and investigate complaints; and failure to validate software used in tracking and trending service and complaints. 4. Failure to validate software used in tracking and trending service and complaints. For...Read More

4) Failure to produce documented evidence to demonstrate the computer controlled/automated system for the manufacturing of liquid oxygen and nitrogen has been validated.Read More

The Food and Drug Administration (FDA) inspected your medical practice on September 3, 4 and 15, 1997, and determined that you are using an unapproved excimer laser system assembled by _____ an engineering consultant with _____ and representatives of _____ This laser system contains software developed by _____ with your input into its design. This...Read More

You failed to respond to calibration failures of the ultraviolet (UV)/visible spectrophotometer as required by your procedures. Instruments were not taken out of service, logbooks did not reflect passing/failing calibrations, certificates of calibrations were incomplete, there was no investigation into the cause of failures and no record was maintained of the corrective action taken as...Read More

Failure to establish and implement an adequate complaint handling system. Although the computerized complaint system used by your firm allows input from all departments, there is no system in place to assure that all service records are reviewed and evaluated for potential inclusion in the complaint handling system.Read More

We acknowledge that you have destroyed key components of the _____ and thus have terminated your _____ of this device. Please advise this office, in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to prevent recurrence in future _____ of violations similar to those listed above....Read More

http://www.fda.gov/cdrh/ode/eedev.htmlRead More

Failure to validate the heat sealing equipment; failure to validate the software in use to calculate GPL and MPL unit values; failure to provide adequate documentation to assure that the product will maintain its functionality throughout its labeled expiration date; and the quality assurance program failed to respond to device quality problems identified as a...Read More

1. Failure to validate major equipment used in the manufacture of medical devices (i.e. computer-driven Kiwa mills, Mori Seiki SL2B lathe, and Citizen lathes);Read More

Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria; failure to establish and maintain an adequate organization structure; and failure of the device master record to include, or refer to the location of, for each type of device, device...Read More

a) Failure to validate finished device testing software, some of which were incorrectly programmed. b) Test software failed to contain a test process/calculation to assure that finished device accuracy specifications were met. e) Failure to establish written and approved manufacturing procedures for finished device test software for MRX multi board and single board devices.Read More

9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.Read More

4. The HPLC computer software (_____, which is used for data acquisition, calculations, and system control, is not validated in that areas such as system operations, system maintenance, change control, data back-up and archival, system security and disaster recovery have not been evaluated.Read More

Your software system which is used to defer donors, does not flag subsequent donations of donors who previously tested positive for certain viral markers. Your procedure, “Computer Entry of Donor Deferrals”, describes four donor status codes (N-Normal, D-temporarily deferred, P-permanently deferred and R-permanently deferred allogenic donor but acceptable autologous donor). However, the software system interprets...Read More

In addition, there was no assurance that the dispensing pump delivers accurate doses. For example, daily accuracy tests on the pump were not documented and the _____ software, revision _____ was not validated to verify installation, operation, and performance.Read More

On May 8, 1996, you submitted an _____ for studies of _____ using an _____ (_____ hereafter “_____”). By letter dated June 7, 1996, (the _____ letter), FDA approved your _____ Under the _____ you may perform _____ to treat _____ for 300 patients at one institution. FDA also requested in the _____ approval letter...Read More

11. Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that there are no procedures for control of the software including procedures to control inappropriate or incorrect changes to the specifications...Read More

You have failed to appropriately validate the sterilization equipment and process in use. You could not provide documented evidence which established a high degree of assurance that the sterilizers and the sterilization process in use are effective and could consistently produce a product meeting its predetermined sterility specifications and quality attributes. You have failed to...Read More

Data management software systems …We are writing to you because on February 28 through March 3, 1997, Investigator James E. Moore from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the products known as the “_____” and the “_____” data management software systems, which are made and marketed...Read More

3. The software was changed, consistent with the new performance specifications. 2. Failure to validate software programs by adequate and documented testing, when computers are used as part of an automated production or quality assurance system, as required by 21 CFR 820.61. For example: a) The validations were not documented for the computer software used...Read More

3. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). This would also be a violation of the Quality System Regulation, 21 CFR 820.70(i). For example, no documentation of specific software changes, which were made to the _____...Read More

3. Failure to maintain written validation protocol and procedures for software and hardware maintenance for the _____ computer system version _____ . 4. Failure to have documented validation for the _____ software and the _____ software. Observation #12. Security controls should be established in writing. They should address the automated test system, as well as...Read More

7/7/97 Solar 7000/8000 Patient Monitors with Software Revision 4A783 units. A software defect is causing incorrect waveform data.Read More

McGaw Stratus Ambulatory Infusion System Model 550 and Alphamed EZ Pump, Model 550 withSoftware Version 2.32.00/2.42.01. Recall #Z-188-9. REASON The pump could under infuse or blood could back up into IV lines when the pumps are running at a slow flow rate with a large infusion set. CODE Serial Numbers: P61145, P71108, P71115, P71125, P71130,...Read More

Metuchen Analytical, Inc. 6/13/97 Drugs 5. Lack of validation data to support the adequacy of the computer software (PC1000 version 2.5 supplied by [purged text] used to run the HPLC systems.Read More

6/5/97 HP M1026a Anesthetic Gas Analyzer with O2 sensor2,284 units. The units may display innacurrate oxygen reading due to software problem.Read More

http://www.fda.gov/cdrh/ode/fetal.htmlRead More

Radia Industry Co. 6/3/97 Sterilization of plasma separators 1. Failure to conduct processing control operations in a manner designed to assure that the device conforms to applicable specifications, as required by 21 CFR 820.100(b)(2). For example, there was also an incorrect maximum conveyor speed observed on February 24, 1997, by the investigator and one member...Read More

We regret to inform you that your certification is incomplete, and therefore inadequate, as submitted. Your certification states that “the computer hardware, firmware and software in my laser allow it to perform all the procedures of the PMA approved device in an identical manner. ” A certification must establish that the limitations of operation required...Read More

Nucletron Corporation 5/21/97 Brachytherapy products b. Specific versions of Veriflex software are ordered, but no SOPs exist which require verification of the version received. Furthermore, the Purchase Order database, used to check incoming components against part numbers, lists obsolete software versions under the current part number. 3. Failure to follow complaint procedures and to maintain...Read More

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Lack of written procedures to identify quality assurance problems reported in complaints and repair requests; failure of screening repair and serice requests to identify complaints; and failure of engineering change orders to include a record of software source code changes 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the...Read More

Bernafon-MAICO Inc. 5/06/97 3. Software revisions have been made without Engineering Change Order (ECO) control, resulting in the distribution of audiometers with unapproved software. ECOs do not include a record of software source code changes and obsolete versions are not archived [21 CFR Part 820.100 (a)(2)]. Software source code is not controlled under the document...Read More

LKC Technologies 5/2/97 Opthlamic Diagnostic Units b. The device history record for a UTAS E-2000 Electrodiagnostic System, serial number “0322,” failed to indicate that the “Final Test” (software virus scan) was performed.Read More

On April 9, 1997, Mr. Mark Tseng and Mr. Emir Galevi of the United States (U.S.) Food and Drug Administration (FDA) conducted a pre-announced inspection of the computer monitor manufacturing facility, Daesun Industrial Co., Ltd., in Kyunggi-Do, South Korea. The FDA inspectors reported several serious deficiencies found in Daesun Industrial Co., Ltd.’s quality control and...Read More

Walter Graphtek GMBH 4/29/97 Digital electroencephalography devices 1. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). For example, there are no documented procedures for the initiation, verification, validation, approval, implementation and documentation of device hardware and software...Read More

IRIS software program. During a Food and Drug Administration (FDA) inspection of your firm located in Frederick, Maryland, on March 23 and 26, 1997, our Investigator determined that your firm manufactures the IRIS software program used for calculating bone density, which is a device as defined by Section 201(h) of the Federal Food, Drug, and...Read More

Institute for Radiological Image Sciences 4/23/97 Software for calculation bone density During a Food and Drug Administration (FDA) inspection of your firm located in Frederick, Maryland, on March 23 and 26, 1997, our Investigator determined that your firm manufactures the IRIS software program used for calculating bone density, which is a device as defined by...Read More

We regret to inform you that your certification is incomplete, and therefore inadequate, as submitted. Your certification states that “the computer hardware, firmware and software in my laser allow it to perform all the procedures of the PMA approved device in an identical manner. ” A certification must establish that the limitations of operation required...Read More

Irwin Memorial Blood Centers 3/20/97 Blood Center Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the...Read More

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Cordis Corporation 3/19/97 Stent Delivery 2. The validation of the balloon forming machines conducted from April 1995 to February 12, 1996 is inadequate due to the following: A. The Programmable Logic Controller which controls the balloon forming machine was not qualified.Read More

Fischer Imaging Corporation 3/19/97 X-ray and mammography systems (a) At least [purged word] systems observed with in-process component and system mis-assemblies such as miswired parts; incorrect or defective printed circuit boards (PCB); missing hardware; defective computer or monitor; incorrect labeling; and defective components such as hand switches, foot switches, collimators, radiation detectors, x-ray tube, cables,...Read More

Automated Voice Systems 3/18/97 Environmental controller 1. Failure to control written manufacturing specifications and processing controls to assure that a device conforms to its original design or any approved changes in that design [21 CFR 820.100]. For example, our investigation determined that your firm failed to ensure that all changes made to your Mastervoice ECU...Read More

Multimedia Medical Systems 3/18/97 Therapac-Plus and Compute-Rx-Plan Software 2. Failure to have approved, dated, and signed Device Master Records for Therpac-Plus Software and related Standard Operating Procedures (SOP) 100 through 133 [21 CFR 820.181]. 3. Failure to establish written procedures for the manufacturing and processing of the finished device [21 CFR 820.160]. There is no...Read More

3/13/97 Sulzer Intermedics Marathon SR & DR Pacemakers 3300 units RX 5000 Software Operating System A software condition caused the parameters of the 2 pacemakers to become reversed. That is, the software cannot distinguish Marathon DR (dual chamber) from Marathon SR (single-chamber) USER PRESET values; whichever values were most recently stored will be recalled.Read More

http://www.fda.gov/cdrh/ode/noninvas.htmlRead More

Separation Technology 3/7/97 Centrifuges 4. Failure to document, review, approve, and validate changes to components, finished devices, labeling, packaging or manufacturing process specifications [21 CFR 820.100(b)(1),(2) & (3)], e.g., there is no documentation of the prior approval of the software specification change initiated 1/24/97 that was an attempt to correct the failures described above. Also,...Read More

Medical Information Technology 3/6/97 Blood Bank Software Manufacturer c. Quality Assurance audits do not cover any quality assurance activities associated with the software customization program. 4. Failure to establish an adequate complaint handling program for the [purged text] as required by 21 CFR 820.198 in that complaints are not reviewed by a formally designated unit...Read More