FDA Warning Letters


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  1. Warning Letter: Failure to validate software (s6357c)

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    Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel [21 CFR 211.68(b)]. Specifically,

    • There was a failure to validate the [redacted] software to assure that all data generated by the system was secure. This software runs the laboratory HPLC equipment, generates and stores data, and performs calculations during testing of raw materials, in-process materials, finished products, and stability samples.
    • User access levels for the [redacted] software were not established and documented. Currently, laboratory personnel use a common password to gain access to the system and there are no user access level restrictions for deleting or modifying data. Furthermore, your system does not have an audit trail to document changes.

    View the original warning letter.


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  2. Warning Letter: Failure to validate software (ucm076315)

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    "The
    validation of the software
    used to perform the trend analysis has not been provided to support your firm's claim that the software can be used effectively to prevent the firm from overlooking complaints. In addition, you have not addressed how you corrected the observations that were made during the FDA inspection. Specifically, you have not
    provided the documentation
    of the investigation into the complaints that were identified in the FDA-483. Please provide for FDA review the documentation of investigation into the complaints, revised procedure QSP8.2-2 "Customer Complaints," and the software validation that was performed on the complaint handling software used for trend analysis.

    View the original warning letter.


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  3. Warning Letter: Failure to record in audit trail (ucm076260)

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    On January 11, 2006, during content uniformity testing of[redacted], the analyst noticed that the first two capsules were out-of-specification

    and the run was aborted. The audit trail for the laboratory data acquisition system does not indicate that the run was aborted and the analyst did not print the sample results or record the failing results in the laboratory notebook.

    View the original warning letter.


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  • Warning Letter: Lack of procedures and instructions (g6173d)

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    • Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use according to an established protocol. For example, databases that are maintained for data analysis and other tracking and trending functions, including complaint and services access databases, have riot [sic] been validated for their intended use.
    • Failure to establish and maintain instructions and procedures for performing and verifying that servicing meets the specified requirements, as required by 21 CFR 820.200(b). Each manufacturer must analyze service reports with appropriate: statistical methodology in accordance with Section 820. 100. For example, your quality group reviews narrative summaries of service reports every two weeks, but the data is not tracked and trended according to a statistical method.

    View the original warning letter.


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  • Warning Letter: No validation protocol (g6139d)

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    "Failure to use the design process for the design changes made to the Biad nuclear imaging system and failure to have written design change control procedures. [21 CFR 820.30(i)] Specifically, the design change (retrofit) your firm made to the Biad nuclear imaging system as a result of a complaint that the detector head on the Biad nuclear imaging system fell and trapped a patient (See item #1 above) was not performed using design controls. There is no formal approval of the change, no risk assessment was documented, and there is
    no verification/ validation protocol
    ."

    View the original warning letter.


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  • Warning Letter: Lack of user level security (g5973d)

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    Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel [21 CFR § 211.68(b)]. Specifically:

    a) Laboratory managers (QC and R&D) gained access to the [redacted] computer system through a common password. Analysts were not required to use individual passwords; they operated the system following the login by the laboratory managers.

    b) Due to the common password and lack of varying security levels, any analyst or manager has access to, and can modify any HPLC analytical method or record. Furthermore, review of audit trails is not required.

    View the original warning letter.


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  • Warning Letter: Failure to indicate reason for change (ucm075728 )

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    Failure to indicate the reason for change in automated data entries [21 CFR 58.130(e)]. In several instances, entries in the [redacted] collection/notes and audit trails failed to provide the reason for changing raw data. For example, audit trail entries for study [redacted]demonstrate that observations of “normal” were removed without an explanation.

    View the original warning letter.


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  • Warning Letter: Failure to maintain accurate, complete, and current records (ucm075362)

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    The deviations noted on the FDA-483, your written responses to those deviations, and issues from our subsequent review of the inspection report are discussed below.

    • Failure to maintain accurate, complete, and current records relating to your participation in an investigation [21 CFR 812.140(a)].
      Responsibilities of clinical investigators include maintaining accurate, complete, and current records relating to the investigator’s participation in an investigation.

    View the original warning letter.


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  • Warning Letter: Failure to follow 21 CFR 11 compliance (g5276d)

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    Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr.  [redacted] that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you to Mr. [redacted], dated January 31, 2005, detailed the name of the EMR system and the means by which study subject information is entered. Please note that Title 21, Code of Federal Regulations, Part 11, “Electronic Records; Electronic Signatures ” outlines specific requirements that must be met for any system that is being used to maintain required records. In addition to the information requested above, please submit the following:

    • Documentation of the validation of your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records;
    • Documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency;
    • Documentation of a secure, computer-generated, time-stamped audit trail that can independently record the date and time of operator entries and actions that create, modify, or delete electronic records, and to verify that record changes do not obscure previously recorded information.

    View the original warning letter.


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  • Warning Letter: Incomplete requirements (ucm075276)

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    Your firm failed to address design input requirements that are incomplete, as required by 21 CFR 820.30(c) [FDA-483, Item 31. Specifically,

    • Functional requirements for the DBSS are in some cases very high level. For example, the requirements for Donor Reporting merely state that the application must enable the user to identify, from a list of persons, the donor on whom the report should be based, and to print an Autologous Unit Status Report, a Donor History Report, a Person Audit Trail Report, a Deferral Audit Trail Report, and an Individual Donor Orders Report for a specific donor. The requirements do not address the files to be accessed, the fields to be printed, or the format of the ave been written for problems with these reports. [redacted] have been written for problems with these reports. For example, [redacted] concerns the military personnel’s SSN appearing where the donor’s SSN should appear on the Donor Audit Trail Report.”

    View the original warning letter.


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