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warningletter

Software Warning Letters

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,...
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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...
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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...
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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,...
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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...
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Internazionale Medico Scientifica 3/5/97 Mammography Systems The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, in that the methods used in, and the facilities or controls used for the manufacturing, packing, storage, and installation are not in conformance with the Good Manufacturing Practice (GMP) for Medical Devices Regulations, as...
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Sunquest Information Systems 3/3/97 Blood Bank Software manufacturer 1. Failure to implement and verify solutions to quality assurance problems [21 CFR 820.20(a)(3)]. For example, our investigation disclosed that representatives of your quality assurance program made recommendations to correct software defects which were not been implemented in a timely manner. Specifically, our investigation determined that some...
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Synaptic Corporation 2/28/97 2. Failure to establish a Device Master Record which includes all device specifications including appropriate drawings, composition, formulation and component specifications. For example, the Master Record for the [purged text] does not include the checksum value of the software, which is used to assure that [purged text] are correctly programmed.
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Diagnostic Specialties 2/10/97Microplate processor 5. Your firm failed to qualify the [purged text] microplate processing instrument, as well as, the [purged word] Control Software and the [purged text] Software, for their intended use.
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Abbott Laboratories 1/31/97 Internal Complaint Handling System During the inspection, our investigator identified a serious limitation inherent in your firm’s complaint database software system. Your current database software system does not provide for the recording of multiple complaint codes for a single complaint. Consequently, some computer generated reports for management review of complaint trends may...
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8. Failure to adequately validate the _____ system software used for inventory tracking of quarantined, rejected, and released materials for finished products and for release and materials transfer functions [21 CFR 211.68].
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a. The reason for changes made to the CNC software programs was not documented nor signed off by a designated individual. b. When the CNC software is changed, the previous versions are overwritten or lost, thus making traceability of the software’s evolution impossible. 4. Failure to conduct processing control operations in a manner designed to...
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WARN 12/05/96 Lady of the Lake Blood Bank Deviations noted included: 1) lack of proper validation of computer system software; 2) failure to establish and implement adequate computer security in allowing software vendor unrestricted modem access and not consistently documenting this access; 3) not conducting a secondary review of computer software modifications; 4) lack of...
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WARN 12/03/96 Berlex Appropriate controls are not exercised over the [purged text] Software, used by Quality Control and Technical Services, to assure that changes in laboratory control records are instituted only by authorized personnel. There are no written procedures defining the appropriate use for the abort, terminate, suspend, restart, and stop functions which are accessible...
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WARN 11/27/96 Stedim S.A. 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: The previous inspection revealed that your firm had not performed any validation of the computer software which controls the...
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WARN 11/14/96 Digisonics 1. Failure to establish and implement adequate quality assurance procedures that provide detailed descriptions of the procedures to be used to perform regression testing after changes to the software have occurred [21 CFR 820.100(a)(2)]. We acknowledge your response to the FDA-483 dated July 10, 1996. The information in your response is inadequate...
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09/09/96 NEURODYNE MEDICAL CORPORATION – Biofeedback units Product labeling for the MEDAC System/3R states, “MEDAC System 3R–is a new configuration for rehabilitation & pain management applications where more than 2 EMGs are needed. All of the stress assessment software features of the standard MEDAC along with 4 channels of surface, PPG (heart rate, pulse height,...
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WARN 09/06/96 S&W MEDICO TEKNIK A/S -Patient monitoring 1. The software for the device identified as the Diascope traveller has been modified to add color to the monitor display. This is a very significant change since a new graphic controller (new hardware) had to be used in addition to a new color LCD display and...
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WARN 09/06/96 NIDEK CO., LTD. Our investigator determined that your firm manufactures sterile and non-sterile products which include ophthalmological, optometrical, semiconductor measurement equipment, and intra-ocular lense. 2. Failure to prepare and implement quality assurance procedures adequate to assure that a formally established and documented quality assurance program is performed. For example: a) The firm has...
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Bennett subsidiary of Trex medical Corp. 8/15/96 (component supplier of high frequency programmable generators for use in imaging systems) 2. Validation protocols for software revisions fail to always specify test parameters such as normal input values, boundary values, out-of-range values and the expected outputs values
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Soring Germany 8/9/96 ultrasonic dissection/aspiration devices 2. Failure to establish and implement specification control measures to assure that the design basis for the device is correctly translated into approved specifications, as required by 21 CFR 820.100(a)(1). For example, there is no documented software validation for the software which operates all devices manufactured by your firm....
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Walter Graphtek Germany 7/1/96 EEG devices 3. Failure to perform planned and periodic audits in accordance with written procedures by appropriately trained individuals not having direct responsibility for the matters being audited, as required by 21 CFR 820.20(b). For example, the following areas were identified as having not been audited under your internal quality assurance...
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GE Medical 6/16/96 X-Ray France 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, the software control processes have not been validated to correct the most serious faults. Failure to subject any...
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Somerset Medical Center Blood Bank 5/29/96 1. The validation of the Meditech Computer System is incomplete and/or inadequate for the following reasons: a. Computer documentation did not include testing procedures, system requirements, and system specifications which were specified to Somerset Medical Center. b. There is no assurance that all program changes resulting from the software...
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Planmed OY 5/9/96 Finland 3. Failure to routinely calibrate measurement equipment, to establish adequate calibration procedures, and to maintain records of calibration, including the next calibration date; and 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...
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Cobe 4/16/96 Hemodialysis 10. Failure to have adequate checks designed and implemented to prevent inaccurate data output, input, and programming errors when automated data processing is used for manufacturing or quality assurance purposes, as required by 21 CFR 820.195. For example, the computer search process for complaints by serial number is not designed to detect...
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Abaxis 4/5/96 blood analyzer 1. Failure to validate computer software programs by adequately documented testing, when computers are used as part of an automated production or quality assurance system (21 CFR 820.61). The computer programs which control the automated assembly of rotor parts, loading of reagent beads, dispensing of reagent beads into proper cuvettes, and...
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Barton Carey Medical Products 4/3/96 our Investigator determined that your firm manufactures vascular and burn compression garments. These garments are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The Inspection revealed that your devices are adulterated in that, the methods used in, or the facilities or controls...
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PIE Medical Equipment 4/1/96 Netherlands ultrasound 1. Failure to maintain records documenting that production and quality assurance measurement equipment is routinely calibrated, inspected, and checked according to written procedures and 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...
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Cabrini Medical Center Blood Bank 2/8/96 14. Failure to maintain written standard operating procedures for the blood bank’s computer system that include: integration of the computer into daily operations; reverting to manual operations when the system is not functioning; control of changes in hardware and software; security procedures to prevent unauthorized access; and maintenance procedures...
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McGHAN Medical Corporation 2/16/96 mammary prostheses The validation of the computerized dip timer system for software version [purged word] and [purged word] fails to assure that the previous files are overwritten when the maximum number of files [purged word] is reached. This is demonstrated by the fact that there was no verification of the file...
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Ionetics 1/29/96 electrolyte analyzers 1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.
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