FDA Warning Letters


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  1. Warning Letter: Failure to validate(g4689d)

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    "Your firm failed to
    validate and approve processes
    whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). Your firm failed to validate the following operations c) Validation of Borland Compiler is incomplete because
    software used to control passwords
    was not addressed (FDA 483, Item #3)."

    View the original warning letter.


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  2. Warning Letter: Failure to Create Validation and CAPA Procedures (g4452d)

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    Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a) and (b). For-example:

    a. The procedure titled corrective Action Handling [redacted] was not approved and implemented to address corrective and preventive action and no established procedure was found to have been in place.

    b. Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program.

    A report dated November 11, 2002 on non-conforming material on [redacted] was filed and a possible cause for the [redacted] was given; however no documentation was provided to verify or validate the adequacy of the corrective and preventive actions.

    Problems were recorded relating to the use of the new dosing/dispensing machine [redacted]; however no documentation/evidence was provided
    to verify or validate the adequacy of the corrective and preventive actions.”

    View the original warning letter.


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  3. Warning Letter: Failure to maintain accurate records (ucm147820)

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    Your firm failed to maintain complete and accurate records from which unsuitable donors could be identified so that products from such individuals would not be distributed [21 CFR 606.160(e)] and records to identify the person performing the work so to provide a complete history of the work performed [21 CFR 606.160(a)(1)]. Specifically, when the investigators requested a search of some of the various donor permanent deferral codes in your [redacted] database, 72 donors had various permanent deferral codes entered into the “Comment” field but these donors did not have a permanent deferral status entered into the “Deferral Code” field of the [redacted] database. The “Comment” field is not referenced for identification of deferred donors. Out of 72 donors, 10 were verified to meet the criteria for permanent deferral.

    View the original warning letter.


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  4. Warning Letter: Failure to validate computer software (g3667d)

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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:

    • [redacted]software validation has not been completed.
    • [redacted] software validation plan does not address the user requirements of inputting data into the [redacted] spreadsheet used as a tool for trending.
    • [redacted] software used for trending has not been validated for its intended uses.

    View the original warning letter.


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  5. Warning Letter: Failure to control security (ucm145034)

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    In addition to the above listed violations, our Investigator noted that the laboratory is using an electronic record system for processing and storage of data from the atomic absorption and HPLC instruments that is not set up to control the security and data integrity in that the system is not password controlled, there is no systematic back-up provision, and there is no audit trail of the system capabilities. The system does not appear to be designed and controlled in compliance with the requirements of 21 CFR, Part 11, Electronic Records.

    View the original warning letter.


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  6. Warning Letter: Electronic files not properly validated or maintained (ucm178453)

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    During the FDA inspection it was discovered that electronic records are used to establish the firm?s Complaint Files, 21 CFR 820.198. However there is no documentation to establish that these electronic records meet the requirements of 21 CFR Part 11, Electronic Records; Electronic Signatures. The requirements of 21 CFR Part 11 are designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records.

    For example, review of your electronic complaint files reveals they have not been properly validated there is no ability to generate accurate and complete copies of records in human readable and electronic form, there is no protection of records] to enable their accurate and ready retrieval, access to your system has not been limited, as well as other significant deficiencies.

    We strongly encourage you to perform a thorough and complete evaluation of all your electronic records in accordance with 21 CFR Part 11 as well as any guidance generated by FDA to assure conformance to our requirements.

    View the original warning letter.


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  7. Warning Letter: MS Access and MS Excel Not Validated (g1483d)

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    Your firm failed to validate several computer databases that are used for quality functions including your Access database , your [redacted] software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i).

    View the original warning letter.


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  8. Warning Letter: Design and Validation (g1121d)

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    References
    software design and validation
    - "...Our inspection disclosed that these devices are adulterated within the meaning of Section 510(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing and storage are not in conformance with the Good Manufacturing Practice (GMP) requirements for the Quality System Regulation as specified in Title 21, Code of Federal Regulation (CFR), Part 820, as follows..."

    View the original warning letter.


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  9. Warning Letter: Failure to comply(g1120d)

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    References validation and lab documentation - "...requires that all drugs be manufactured, processed, packed, and held according to current good manufacturing practice. No distinction is made between active pharmaceutical ingredients and finished pharmaceuticals, and failure of either to comply with CGMP constitutes a failure to
    comply with the requirements
    of the Act...."s."

    View the original warning letter.


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  10. Warning Letter: Computer security (g1148d)

    Tags: |
    References
    computer security
    , using another person's login - "During the inspection, FDA investigators documented violations of Section 501 (a) (2)(B) of the Federal Food. Drug and Cosmetic Act (the Act) and deviations from the applicable
    standards and requirements
    of Title 21, Code of Federal Regulations, Parts 211 and 600-680, Subchapter F, (21 CFI? 211 and 600- 680)..."

    View the original warning letter.


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