Medical Device Manufacturer


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Warning Letter: Failure to establish and maintain procedures for validating device software (ucm474240)

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“Failure to establish and maintain procedures for validating the device software for infusion pumps to ensure that devices conform to defined user needs and intended uses.”

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Warning Letter: Failure to validate software (ucm465665)

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“Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).

For example, your firm uses the software [redacted], developed by [redacted], to document, maintain, and track customer complaints electronically. However, as stated by your firm’s Director of Quality Assurance (QA) & Regulatory Affairs (RA) during the inspection, the software does not generate time-stamped audit trails to independently record the date and time of operator entries and actions that create, edit, or modify electronic records.”

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FDA Warning Letter: Validations of software processes not completed (ucm458487)

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“”CAPA QS-13-006 identified corrective actions to your firm’s software validation procedure and identified 50 software processes that were not validated. Your firm closed the CAPA as effective on April 15, 2015; however, the validations for 38 of the identified software processes were not completed [Kurihara-shi, Miyagi].

The adequacy of your firm’s responses cannot be determined at this time. Your firm initiated a CAPA to address the above deficiencies. However, your firm has not completed implementation of its corrective actions and CAPA effectiveness verifications for this observation.”

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Warning Letter: No records demonstrating the software was validated (ucm459656)

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“Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).

During an inspection of your firm located in Round Rock, Texason June 16, 2015 through July 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the ECG Check Application and ECG Check Wireless Lead Cardiac Monitor (ECG Check Monitor)…

Your firm’s “Design Validations” procedure Revision 1 dated May 22, 2015, states software should be tested according to a test plan and requires the results of this software validation to be maintained in the design history file (DHF). Your firm does not have any records demonstrating the ECG Check Application software was validated.”

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Warning Letter: Lack of testing of software interfaces (ucm448655)

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“An analysis to determine if other software products manufactured have had similar failure modes due to lack of testing of software interfaces.”

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Warning Letter: No procedures on how to enter data in the electronic system (ucm444827)

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“Your procedure has not been updated to reflect the change that was made in 2011 to document all complaints on a form in your electronic system, and not on the hard copy “Product Inquiry/Complaint form” as required by section 6.3 of your complaint procedure. Additionally, there are no procedures on how to enter data in this electronic system.”

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Warning Letter: Procedures not defined (ucm443561)

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“Your firm states that service call logs were reviewed and “Calls were searched for Key Words to filter for obvious complaint language;” however, your firm did not define what constitutes “obvious complaint language” and did not define a procedure for implementing this filter.”

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Warning Letter: Procedures not implemented (ucm442205)

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” Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically,

a. Your “Corrective and Preventive Action” procedure, SOP 019, Rev. 16, is not being implemented in that:

1. The Engineering Change Orders being initiated to change the designs of the printed circuit boards due to solder ball nonconformances identified during the validation of surface mount technology process (SMT) are not being managed as a corrective action.

2. Nonconformances, such as missing components, solder balls, shifted/tombstoned components, and bad solder joints on the printed circuit boards, which occur during the surface mount technology process, are not being captured as sources of quality data that are analyzed to identify existing and potential causes of nonconforming product.”

Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically,

The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings were not documented. Therefore, it is unknown if you are currently operating the reflow oven within your validated parameters.

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Warning Letter: No evidence of validation (ucm442129)

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“Additionally, your firm has made 21 software upgrades since the release of the system, 17 of which were not evaluated for potential correction and removals. All of these software upgrades have been upgraded to all field systems. These software upgrades included fixes for identified hazards such as fluid deficit issues in software revisions G”, “L”, “N” and “S” all with an assigned severity level of “10”.

Your firm does not have evidence of review or acceptance of validated processes used by critical suppliers to manufacture components for your fluid management device.”

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Warning Letter: Failure to adequately validate software (ucm441879)

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“Failure to adequately validate software used as part of production and quality systems for its intended use according to an established protocol as required by 21 CFR 820.70(i). Specifically, you did not validate your CNC Lathe and MAS 90 software used in manufacturing and labeling, respectively.”

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