FDA Warning Letters


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  1. 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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  2. Warning Letter: Failure to validate computer software (ucm399523)

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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).

    View the original warning letter.


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  3. Warning Letter: Failure to validate computer software (ucm399519)

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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, during the inspection your firm confirmed that its software program [redacted] version [redacted] released on August 28, 2009, for documenting condom production control tests has not been validated for its intended uses.

    View the original warning letter.


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  4. Warning Letter: Failure to validate computer software (ucm377116)

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    Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses [redacted] to generate, store, and disseminate standard operating procedures, forms, and other records. [redacted] is also used by your firm to generate and store Device History Records (DHRs) and other quality system data. During the inspection, your firm indicated that the procedure titled, “Validacion del software utilizado en el sistema de calidad, GC-E-07-49, Rev. 00,” dated March 14, 2011, states that validation is concentrated on software and documents used in the quality system since there is no software used in your firm’s manufacturing equipment. However, your firm could not produce any evidence to demonstrate that the software programs were validated for their intended use.

    View the original warning letter.


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  5. Warning Letter: Failure to validate computer software (ucm377097)

     
    “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: Document No. IN-26_01_002, No. 1, dated March 25, 2013, Validierungsmasterplan [Validation Master Plan] developed as part of CAPA 2335, states that [redacted], [redacted], and [redacted], are software programs that are considered critical, which requires software validation. These programs have not been validated by your firm.”

    View the original warning letter.


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  6. Warning Letter: Failure to exercise appropriate controls on data (ucm369407)

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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)).

    Your firm’s [redacted] “Jasco LC-Net II” HPLC instruments do not have restrictions in place to prevent any change or deletion of analytical raw data. Additionally, there is no audit trail in place to determine any previous deletion of raw data.

    View the original warning letter.


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  7. 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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  8. Warning Letter: Failure to Establish Validation Program (ucm366715)

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    "your firm failed to establish a
    validation program
    for the computer software Microsoft Dynamics used for production, inventory, lot number generation, and laboratory test methods used for raw material, bulk, and finished product test release.  Your firm also uses the Microsoft Dynamics program to assist your quality unit for product, document and component control.

    View the original warning letter.


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  9. Warning Letter: No CAPA Procedure (ucm 360143)

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    These violations include, but are not limited to, the following:

    Failure to establish and maintain adequate procedures for implementing corrective and preventive action and failure to document all activities under 21 CFR 820.100 and their results, as required by 21 CFR 820.100(a).

    For example: Your Quality System Manual, dated 10/09/2012, Rev. A, Section 8.4 states that your firm has established procedures to document and analyze quality data from complaints, internal audits, supplier performance and non-conforming materials. Section 8.5 states that your firm has implemented a corrective and preventive action (CAPA) program to eliminate the cause of nonconformities in order to prevent recurrence. However, your firm does not have any written CAPA procedures. In addition, you have no records of analyzing quality system data obtained through sources such as complaints, internal audits, supplier performance and non-conforming materials, to determine if a CAPA action is required.

    View the original warning letter.


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  10. 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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