FDA Warning Letters


  1. Warning Letter: Failure to document validation (ucm201895)

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    Failure to maintain a design history file for the “Defender” air filtration system, as required by 21 CFR § 820.300). Specifically, your firm  could not locate the design inputs, outputs, verification and validation documents, design reviews and design changes for the “Defender”.

    View the original warning letter.


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  2. Warning Letter: Failure to validate CAPA proedures (ucm201897)

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    Your firm’s Corrective and Preventive Action Practice form does not specify that you will verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device as required by 21 CFR § 820.100(a)(4). For example, your firm needs to perform effectiveness checks in order to verify that the corrective and preventive actions were effective  as to the intended purpose of the action and that new issues or concerns are not introduced.
    Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation as required by 21 CFR § 820.30(i). Specifically, your firm has failed to establish and maintain design control procedures for the design changes that were made to your devices during the months of May and June of 2009.

    View the original warning letter.


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  3. Warning Letter: Failure to maintain adequate procedures (ucm200878)

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    Failure to establish and maintain adequate procedures to identify all the action(s) needed to correct and prevent the recurrence of nonconforming products and other quality problems, as required by 21 CFR 820.100(a)(3). For example: You have decided to issue a software update as a corrective measure for resistor related issues. However, our review indicates that the latest software update is only a method of detection and will not prevent resistor failures.  “Failure to review and evaluate all complaints to determine whether an investigation is necessary and maintain a record that includes the reason when no investigation was made, as required by 21 CFR 820.198(b).

    View the original warning letter.


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  4. Warning Letter: Failure of adequate controls (ucm200384)

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    Failure to have adequate controls to prevent manipulation of raw data during routine analytical testing. “For example, your firm’s laboratory analyst had modified printed raw data related to the IR Spectra test of [redacted] and [redacted]. We are concerned that the lack of security or system controls allows for this practice.

    View the original warning letter.


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  5. Warning Letter: Incomplete design validation (ucm200389)

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    Design validation failed to include testing of production units under actual or simulated use conditions as required by 21 C.F.R. 820.30(g). For example, the MedStar System design history records do not include documentation to demonstrate that the physiological data (e.g. blood pressure and heart rate readings) obtained from the patient is the identical data transmitted from the MedStar Collection Server.

    View the original warning letter.


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  6. Warning Letter: Lack of security for electronic data (ucm197966)

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    Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)].

    For example, your firm lacks systems to ensure that all electronic data generated in your Quality Control laboratory is secure and remains unaltered. All analysts have system administrator privileges that allow them to modify, overwrite, and delete original raw data files on the [redacted] used [redacted] in the High Performance Liquid Chromatography (HPLC) units. There are no procedures that address the security measures in place for generation and modification of electronic data files for these instruments used for raw material, in-process, finished product and stability testing. In addition, your firm’s review of laboratory data does not include a review of an audit trail or revision history to determine if unapproved changes have been made.
    View the original warning letter.


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  7. Warning Letter: Failure to Automate Data Processing Systems (ucm190816)

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    You have failed 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 the production or the quality system, as required by 21 CFR 820.70(i). Specifically, there is no record of validation for software in the [redacted] which is used to make components for the aspirating dental injection syringes.

    View the original warning letter.


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  8. Warning Letter: Failure to Validate Spreadsheets (ucm185865)

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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, when requested, no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs.

    View the original warning letter.


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  9. Warning Letter: Failure to validate off-the-shelf software (ucm185181)

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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 off-the-shelf software that generates the labels for the dental alloys. The off-the-shelf software has not been validated for this use.

    View the original warning letter.


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  10. Warning Letter: Failure to validate software (ucm185261)

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    Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 CFR § 820.70(i). For example, the [redacted] and [redacted] software used to generate instruction manuals, clinician’s manuals and prescription device labels for the [redacted] devices has not been validated.

    View the original warning letter.


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