FDA Warning Letters


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  1. Warning Letter: Failure to establish and maintain procedures for validation (ucm436707)

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    “Your software development / validation does not include written procedures, structural and regression testing, and code reviews.

    1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,

    a. Your software development /validation:

      1. does not include written procedures covering the development/validation of the software used in your devices
      2. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
      3.  software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.

    ….

    c. The available clinical studies documentation for the following Evolution Oxygen Conservers:

        1. did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
        2. did not include the baseline saturation levels or the device settings for the patients.”

    View the original warning letter.


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  2. Warning Letter: QC personnel created unauthorized data folders on laboratory computerized systems without appropriate oversight (ucm432709)

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    “Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

    QC personnel created unauthorized folders on laboratory computerized systems without appropriate oversight. Our review of the HPLC Empower III data collected in 2013-2014 in the commercial QC laboratory found a data folder entitled “WASH.” According to your management, the folder was intended for column wash injections using blank solvent prior to and following sample runs, although you have no standard operating procedure (SOP) detailing this process. One of your laboratory analysts stated that this folder does not contain any standard or sample injection results. However, our investigator found that this folder contained a total of 3,353 injection results, some of which appeared to be samples.

    As part of your comprehensive evaluation and risk assessment, include a detailed description of all computerized systems in your facility used for testing drugs. This description should include information on each electronic folder that was not created pursuant to a valid SOP and an assessment of every file in each such folder, including information about the sample (product), date of test, lot number and original test result over the last five (5) years, except for data relating to exhibit batches, in which case there is no time limitation. Also provide specific information about all retests during these time frames, where an initial out-of-specification or out-of-trend result was disregarded without an investigation and the date on which you became aware such information had been disregarded. In addition, for each batch, provide the number of injections performed and chromatograms reviewed, and of those, the number that were used to generate a reported result. Furthermore, provide an updated assessment on the possible effects of your firm’s practices on the quality, safety, and efficacy of the drugs you manufacture or plan to manufacture, including drugs covered by approved or pending applications.

    Also describe the procedures established to manage and retain all computerized data.

    View the original warning letter.


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  3. Warning Letter: Lack of controls, such as audit trails, to prevent substitution, overwriting, or changes of electronically stored data (ucm431456)

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    “The trial injection data was stored in the “Trial” folder located on a PC with no audit trail linked to the HPLC instrument…

    The audit trail for the dissolution analysis of the 9-month long-term stability sample of [redacted] USP [redacted] mg Tablets batch [redacted] conducted on March 22, 2014, showed a single manual injection that was not included in the official test results package. A manual “trial” sample injection from vial position [redacted] at 12:29 pm was injected between the Set [redacted] and Set [redacted] analytical sequences. No deviation was documented regarding the extra sample injection. In addition, the original injection data obtained for vial position [redacted] was overwritten and not saved. Because the original data was overwritten, you did not review and evaluate it as part of your batch release decision…

    Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

    FDA investigators discovered a lack of basic laboratory controls to prevent changes to electronically stored data. The following examples show that you lack effective control of the integrity of instrument output data:
    The ten Shimadzu HPLC instruments in the QC “commercial” laboratory were configured to send acquired injection data to PCs without audit trails.

    There was a lack of controls to prevent substitution or overwriting of data. The [redacted] audit trail dated January 6, 2014, for HPLC MLG/QC/12/026 and the [redacted] audit trail dated January 15, 2014, for HPLCs MLG/QC/12/031 and MLG/QC/12/027 each showed sample injections marked with the same small graphic symbol. For each of these entries, you replaced the original injection sequence data with data from a single manual injection and failed to save the original sequence data.

    A “File Note” dated February 10, 2014, signed by the QC Head, established that the printed data used for batch disposition decisions from the Metrohm Titrando Instrument MLG/QC/12/048 hard drive was not necessarily the complete data for a batch. Our inspection found that data on the instrument was selected for use and was not protected from change and deletion. Notably, the audit trail capability of this QC “commercial” laboratory instrument was not enabled, even after creation of the “File Note.”

    View the original warning letter.


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  4. Warning Letter: Production Software not validated (ucm446847)

     
    “Software used as part of production and the quality system has not been validated for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, software validation was not conducted for the following pieces of equipment: [Redacted]”

    Automated Production Equipment
    Quality Inspection Equipment
    [redacted]
    [redacted]
    [redacted]
    [redacted].”

    View the original warning letter


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  5. Warning Letter: Software specifications were not maintained (ucm429201)

    “A device master record has not been adequately maintained, as required by 21 CFR 820. 181. For example, specifications for the various components of the device were not maintained; software specifications were not maintained; production process specifications and procedures were not maintained; quality assurance procedures and acceptance criteria were not maintained; packaging and labeling specifications were not maintained; and installation, maintenance and servicing procedures and methods were not maintained.

    View the original warning letter .


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  6. Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

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    “Failure to establish and maintain procedures to control all documents, as required by 21 CFR
    820.40. For example, your firm failed to follow its Documentation Management procedure since it
    used electronic signatures to approve numerous procedures. Your firm’s procedure states that
    there are no currently-approved electronic signature systems implemented at your firm.”

    View the original warning letter.


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  7. Warning Letter: Failure to document digital changes and complaints (ucm421235)

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    No records of identification, validation or verification, review, or approval were available for design changes to the SimulCare resulting in the SimulCare II. The changes included new digital controls… Failure to ensure that suppliers and contractors were evaluated and selected based upon their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm utilizes various suppliers for components of your devices, including PCBs [Printed Circuit Boards]…your firm failed to record and document investigation of oral complaints related to burnt-out microchips… Specifically, the SimulCare II was cleared under K083202; however, your firm’s promotion of the device provides evidence that the device was modified including a change from analog knobs utilized to control the strength and duration of therapy to digital button controls now utilized for the same function.

    View the original warning letter.


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  8. Warning Letter: Failure to have proper controls (ucm421988)

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    Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.

    Your firm did not have proper controls in place to prevent manipulation of your laboratory’s electronic raw data. Specifically, your NuCon 5700 gas chromatographs (GCs) did not have access controls that would prevent the deletion or altering of raw data files. In addition, the GC software lacked active audit trail functions to record any changes to the data, including the previous entries, who made the changes, and when the changes were made. The use of audit trails for computerized analytical instrumentation is essential to ensure the integrity and reliability of the electronic data generated.

    During the inspection, your management explained that the laboratory practice was to delete the raw data files once the chromatograms were printed. As such, your firm did not retain complete raw data from testing to ensure the quality of your APIs. Specifically, electronic raw data files, supporting your GC testing for release (assay) were deleted.

    Failure to have appropriate controls for issuance of batch records.

    Our inspection found that batch records were uncontrolled in that operators had the ability to print batch records from their personal computers. In addition, various uncontrolled blank manufacturing batch records were found in a binder located in the production office.

    View the original warning letter.


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  9. Warning Letter: Complaints closed without investigation (ucm42084)

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    Your firm’s CAPA trending of production hardware failure non-conformances is inadequate in that 39 production hardware failure non-conformances reviewed found you stated a justification for not opening a CAPA for each of these non-conformances as “NCMRs are trended periodically and CAPAs are issued according to this trending.”

    View the original warning letter.


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  10. Warning Letter: Procedure not implemented (ucm416625)

    Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established, as required by 21 CFR 820.50. Specifically,

    a. Your firm has not defined and documented the specific requirements and specifications to be met by your suppliers of audiometer device components such as speakers and keypad membranes.

    b. Your Vendor Qualification SOP #E-001, Rev A, has not been implemented. Section 5.3 requires audits of vendors of custom components and services, unless they have received ISO registration and a copy of the ISO registration is obtained. Your firm has not performed audits of custom device components such as the keypad membrane and the firmware, and there is no ISO registration for those firms on file.

    View the original warning letter.


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