Training Related


  1. Warning Letter: Failure to capture electronic data (ucm399364)

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    AMKS TRL monitoring failed to identify and correct a clinical investigator’s failure to collect study subjects’ data on protocol-specific case report forms (CRFs), as required by Protocol [redacted]. We note that during the inspection, you indicated that AMKS TRL did not use any paper CRFs or electronic data capture to record study subjects’ data.

    View the original warning letter.

     

     


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  2. Warning Letter: Failure to follow procedures (ucm401361)

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    The FFDM manufacturer QC (excluding monitor and printer QC) procedures for digital unit 3, Lorad (Hologic), SEL, room Mammography were not followed. [See 21 CFR 900.12(e)(6)]

     

    View original warning letter.


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  3. Warning Letter: Uncontrolled Excel spreadsheets (ucm369409)

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    For example, your firm failed to have adequate procedures for the use of computerized systems used in the QC laboratory. At the time of the inspections, your QC laboratory personnel shared the same username and password for the operating systems and analytical software on each workstation in the QC laboratory. In addition, no computer lock mechanism had been configured to prevent unauthorized access to the operating system. The investigator noticed that the current QC computer users are able to delete data acquired. In addition, the investigator found that there is no audit trail or trace in the operating system to document deletions.

    Additionally, at the Aarti Drug Limited facility (FEI 3009688205), the investigator noticed that the use of the Excel® spreadsheets in analytical calculations are neither controlled nor protected from modifications or deletion. The investigator noticed that the calculation for residual solvent for [redacted] uses an Excel spreadsheet that has not been qualified. We are concerned about the data generated by your QC laboratory from non-qualified and uncontrolled Excel spreadsheets.

    View the original warning letter.


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  4. Warning Letter: Medical device company failed to validate computer software (ucm 355751)

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    Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, your firm’s design verification procedure does not require that test equipment and software are fully validated, as needed, and prior to use in design verification activities.

    View the original warning letter.


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  5. Warning Letter: Compliance training (ucm2275453)

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    “Your firm also failed to establish SOPs to ensure the following: (1) that all ADE information obtained from all sources are promptly conveyed to appropriate Jazz personnel and reviewed, in particular information obtained by your contracted central pharmacy and call center; (2) that all ADEs are evaluated against the U.S. package insert for seriousness and expectedness; (3) that all ADEs are reported accurately from source documentation to the FDA Form 3500A; and (4) that all ADEs that are the subject of 15-day Alert reports are promptly investigated and that all attempts to obtain additional information about the adverse experiences are recorded (as required by 21 CFR 314.80(c)(1)(ii)).

    View the original warning letter.


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  6. Warning Letter: Inadequate employee training (s6660c)

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    Failure to ensure that all employees have the necessary training and experience to perform their jobs, as required by 21 CFR 820.25 (b). Specifically employees who manage, perform, and assess work affecting quality have not been adequately trained as members of your firm’s quality unit. Quality Assurance employees have not performed effectively in conducting complaint investigations, corrective/preventive action activities, design activities, internal audits, risk analysis and/or document reviews. You ran out of existing safety pins for the circumcision tray and a larger safety pin was substituted. You received at least two customer reports of excessive bleeding. The change to the larger safety pin was made by the Product Family Coordinator (PFC). The product authorization form was not signed and did not proceed through the change process. Other examples of inadequate employee training are the failure to implement adequate corrective and preventive actions to complaints of crystallizing alcohol in kits and a complaint of weak seals.

    View the original warning letter.


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  7. Warning Letter: No documentation of employee training (s6597c)

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    Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b). For example, there is no documentation of any training of any current employees with regard to their assigned responsibilities, although your training procedures require documentation of training. … Failure to conduct quality audits; and failure to implement audit procedures to assure that the quality system is in compliance with the established quality systems requirements and to determine the effectiveness of the Quality Systems, as required by 21 CFR § 820.22.

    View the original warning letter.


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  8. Warning Letter: Employees not adequately trained (ucm076532)

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    Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). For example: “a. Training records for a sterilizer operator and packager were requested at your Asheboro, NC, facility during the 2007 FDA inspection. Out of five (5) training records requested for the sterilizer operator, only two (2) were available. Two (2) training records were requested for the packager and only one (1) record was available.” “b. A number of documents were collected demonstrating that employees were not adequately trained, at your [redacted] facility.

    View the original warning letter.


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  9. 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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