FDA Warning Letters


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  1. 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.”

    View the original warning letter.


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  2. 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.”

    View the original warning letter.


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  3. 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.

    View the original warning letter.


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  4. 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.”

    View the original warning letter.


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  5. Warning Letter: No active audit trail (ucm443247)

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

    You lacked controls to prevent the unauthorized manipulation of your laboratory’s electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data. Furthermore, the computer software for this equipment lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change. Audit trails that capture such critical data about the quality of your batch production should be reviewed as part of the batch review and release process.”

    View the original warning letter.


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  6. 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.”

    View the original warning letter.


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  7. Warning Letter: Failure to develop adequate written procedures (ucm442577)

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    1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, Your procedures addressing corrective and preventive actions, “Procedures for Corrective and Preventive Action”, PCPA-00, dated10/5/10 and “Measurement and Analysis” procedure, MA-00, dated 10/5/10, are not adequate in that: a) Your procedures do not address:

    1. How and how often each data source will be analyzed to identify existing and potential causes of nonconforming product.

    2. Initiating a corrective and preventive action commensurate with the significance and risk of the nonconformity.

    3. Verifying and validating corrective and preventive actions to ensure such action is effective and does not adversely affect the finished device.

    4. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.


    5. Failure to establish and maintain procedure for identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, a sticky note on the “Chaps” instructions sheet stating “No Longer Need F Velcro Lengths” is the only documentation for the change to receive the elastic with the Velcro already sown onto it. This design change did not go through your formal change control as required by “Change Control” procedure, CC-00, dated 10/5/10.

    View the original warning letter.


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  8. Warning Letter: No audit trail function was enabled (ucm440966)

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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)).

    Specifically, your high performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition software, TotalChrom®, did not have sufficient controls to prevent the deletion or alteration of raw data files. During the inspection, the investigator observed that the server that maintains electronic raw data for HPLC and GC analyses (the J drive) contains a folder named “Test,” and that chromatographic methods, sequences, and injection data saved into this folder can be deleted by analysts. The investigator also found that data files initially created and stored in the “Test” folder had been deleted, and that back-up files are overwritten [redacted].

    In addition, because no audit trail function was enabled for the “Test” folder, your firm was unable to verify what types of injections were made, who made them, or the date or time of deletion. The use of audit trails for computerized analytical instrumentation is essential to ensure the integrity and reliability of the electronic data generated.”

    View the original warning letter.


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  9. Warning Letter: Inadequate audit trails and password protection (ucm436268)

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    “a. You did not retain complete raw data from testing performed to ensure the quality of your APIs. For example, your firm could not provide electronic raw data supporting your High Pressure Liquid Chromatography (HPLC) testing in your Validation Report BP-VR-0701/2010.

    b. You failed to retain complete raw data documenting the weights and calculations used in method validation as specified in your standard operating procedure (SOP) “Recording of Raw Data.”

    c. Your analyst selectively invalidated data during related substance testing. For example, for [redacted], batch [redacted] on May 15, 2013; you did not retain data from all six injections used for the initial system suitability. Your analyst discarded one of the six injections performed with no justification.

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

    The inadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produce. Specifically,

    a. Your firm did not have proper controls in place to prevent the unauthorized manipulation of your laboratory’s raw electronic data. Your HPLC computer software lacked active audit trail functions to record changes to analytical methods, including information on original methodology, the identity of the person making the change, and the date of the change. In addition, your laboratory systems did not have access controls to prevent deletion or alteration of raw data. During the inspection, your analysts demonstrated that they were given inappropriate user permissions to delete HPLC data files.

    b. Moreover, the gas chromatograph (GC) computer software lacked password protection allowing uncontrolled full access to all employees.”

    View the original warning letter.


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  10. Warning Letter: Failure to prevent unauthorized access or changes (ucm421544_Amended)

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    Your firm released [redacted] API batch [redacted] with an unknown peak present in the residual solvents chromatogram. Although this unknown peak was not a part of your historical impurity data, neither the analyst nor the supervisor apparently noticed or evaluated this unknown peak during their reviews.

    Subsequently, a customer complaint was received for this batch, and your investigation identified the unknown peak as [redacted]. Your firm found that this peak was a result of a contamination that occurred during your manufacturing process.

    In response to this letter, provide the corrective actions implemented to ensure that all laboratory data is appropriately analyzed, accurately reported and approved by your quality unit.
    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 the unauthorized manipulation of your electronic raw data. For example,

    a. The inspection found that the audit trail feature for your gas chromatography (GC) instruments was not used until October 2013, even though your 2009 GC software validation included a satisfactory evaluation of the audit trail capability.

    b. There is no assurance that you maintain complete electronic raw data for the [redacted] GC instruments, the Malvern particle size analyzer, and the ultraviolet (UV) spectrophotometer. Our inspection found that these instruments were connected to stand-alone computers that stored the data and that the data could be deleted.

    c. Prior to our inspection, your firm failed to have a back-up system for the data generated by one of the [redacted] Fourier transform infrared spectrometers, the polarimeter, the UV spectrophotometer and the Malvern particle size analyzer.

    View the original warning letter.


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