FDA Warning Letters


  1. Warning Letter: Failure to establish procedures (ucm279180)

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    Failure to establish and maintain adequate 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). For example: the device design was revised to include an [redacted] for both the ActiveCare DVT and ActiveCare+SFT devices. Your firm’s design validation report No.71365539, Safety Technical Report OVP, includes design verification test results where the device was tested at [redacted] but does not appear to include testing of production units under actual or simulated conditions as indicated in your Design Verification and Validation procedure referenced in your Design Changes Procedure.

    View the original warning letter.


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  2. Warning Letter: Compliance training (ucm2275453)

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    “Your firm also failed to establish SOPs to ensure the following: (1) that all ADE information obtained from all sources are promptly conveyed to appropriate Jazz personnel and reviewed, in particular information obtained by your contracted central pharmacy and call center; (2) that all ADEs are evaluated against the U.S. package insert for seriousness and expectedness; (3) that all ADEs are reported accurately from source documentation to the FDA Form 3500A; and (4) that all ADEs that are the subject of 15-day Alert reports are promptly investigated and that all attempts to obtain additional information about the adverse experiences are recorded (as required by 21 CFR 314.80(c)(1)(ii)).

    View the original warning letter.


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  3. Warning Letter: Inadequate records (ucm271583)

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    Failure to maintain adequate drug disposition records raises concerns about subject safety and data integrity. We acknowledge that your written response states that upon your discovery of both the lack of drug accountability and the missing vials, pharmacy and research SOPs were evaluated and revised; and that future studies at your site will be conducted under the umbrella of US Oncology Research, which has an electronic drug accountability system. However, as the clinical investigator, it was your responsibility to ensure that adequate records of the disposition of the drug were maintained; and US Oncology Research’s policies, procedures, and activities do not negate your responsibility as the clinical investigator.

    View the original warning letter.


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  4. Warning Letter: Failed to exercise appropriate controls (ucm270668)

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    Your firm has failed to exercise 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 C.F.R § 211.68(b)].  For example, your firm has failed to periodically conduct back-up procedures for the [redacted] Server, Equipment [redacted] (Building [redacted], Room [redacted]) since August 2010. This server was used to store, back-up, and/or archive raw test data from computer systems (Software:[redacted]controlling and monitoring [redacted] High-performance liquid chromatography (HPLC) systems in accordance to SOP, [redacted]titled, [redacted].” During the inspection, the [redacted]server was observed as being tagged out-of-service since February 2009.

    View the original warning letter.


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  5. Warning Letter: Failure to establish adequate procedures(ucm271368)

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    Failure to establish adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, testing records for timers received on March 27, 2009; April 9, 2009; April 17, 2009; and May 28, 2009, only included a computer printout of the final data as the original raw data of the testing conducted and acceptance data for each of the timers were not maintained.

    View the original warning letter.


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  6. Warning Letter: Failure to establish validation procedures (ucm268244)

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    Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

    View the original warning letter.


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  7. Warning Letter: Failure to establish procedures (ucm268059)

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    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures. You also have no documentation of design validation or design change controls for the Antalgic-Trak, including no documentation of risk analysis or structural [redacted] testing of the embedded software.

    View the original warning letter.


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  8. Warning Letter: Failure to follow procedures (ucm268034)

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    Failure to establish and maintain adequate procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g).

    View the original warning letter.


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  9. Warning Letter: Failure to validate computer software (ucm265239)

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    Failure to validate computer software for its intended use according to an established protocol , as required by 820.820.70(i). Your firm uses the [redacted] for in-process and final product testing for the [redacted] and the [redacted]. Your firm conducted software validation for the [redacted] and the results are included in the Software Validation Report, dated February 11, 2010.

    View the original warning letter.


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  10. Warning Letter: Failure to document software validation (ucm258853)

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    Failure to adequately document software validation activities and results for computers or [redacted] systems used as part of production, as required by 21 CFR 820.70(i). For example, there is no documentation of validation having been performed on the software systems that operate the [redacted], which moves [redacted] pallets from [redacted] to shipping[redacted]. There are no documented quality system procedures for the control of the [redacted] finished product warehouse (UP [redacted]) and your firm’s [redacted] department does not operate within your firm’s quality system.

    View the original warning letter.


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