FDA Warning Letters


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  1. Warning Letter: Missing Validation Testing (ucm 359625)

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    Your firm does not have a design history file (DHF) for the Meridian DR 200 single panel X-ray system. The system is comprised of a workstation, flat panel detectors, acquisition software and X-ray hardware. Missing elements of the DHF include:
    • A design plan for the project
    • Established or approved design inputs/outputs for the system
    • Verification or Validation testing for the system
    • Design Transfer
    • Risk Management for the system
    • Design Reviews.
    Your firm does not have procedures to describe the content of your Device History Records (DHR’s). In addition, eleven of eleven DHR files reviewed showed that all were incomplete as the only record in the files was your testing of the flat panel detectors, which is only one part of the X-ray system. The DHRs do not include installation records; records of any non-conformities; records regarding the X-ray hardware, workstation or acquisition software; or records of final product testing and quality release of your systems.

    View the original warning letter.


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  2. Warning Letter: Firm not reporting all electronic results obtained (ucm 361553)

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    We observed and documented practices during the inspection that kept some samples, data and results outside of the local systems for assessing quality. This raises serious concerns regarding the integrity and reliability of the data generated at your Kalyani plant. For example,

    a. Our review of the Chromeleon and Empower II software found that your firm was testing samples unofficially, and not reporting all results obtained. Specifically, “test,” “trial” and “demo” injections of intermediate and final API samples were performed, prior to performing the tests that would be reported as the final QC results.

    b. Out-of-specification or undesirable results were ignored and not investigated.

    c. Samples were retested without a record of the reason for the retest or an investigation. Only passing results were considered valid, and were used to release batches of APIs intended for US distribution.

    d. Unacceptable practices in the management of electronic data were also noted. The management of electronic data permitted unauthorized changes, as digital computer folders and files could be easily altered or deleted.

    View the original warning letter.


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  3. Warning Letter: Failure to follow Protocol (ucm 366762)

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    Protocol [redacted] required that you dispense a handheld electronic device (LogPad) to subjects at Visit 2, prior to surgery, and that the subjects record their pain assessments in the LogPad during the study. You did not dispense a LogPad to Subject 09-006 at Visit 2 on March 4, 2011, because the subject was sedated and on a ventilator. In addition, five pain assessments for Subject 09-006 were entered into the LogPad by the study coordinator, rather than by the subject. During the inspection, your study coordinator indicated that she used the subject’s login code and entered the subject’s pain-assessment scores into the LogPad when the subject was unable to provide a pain score. In your October 3, 2012, written response, you acknowledged that the LogPad was not dispensed to Subject 09-006 prior to surgery. You noted that after surgery, the subject was put on a “vent” (ventilator), was sedated, and was unable to participate in the evaluation of pain, via the LogPad or otherwise….

    …By failing to ensure that pain-assessment data were entered only by the subjects, as required by the protocol, you compromised the validity and integrity of data collected at your site. Protocol [redacted] required that the subjects record their pain assessments in the LogPad during the study. For Subject 09-006, the LogPad contained assessments purportedly made and entered by the subject; however, five pain assessments were entered by the study coordinator and reflect the study coordinator’s or nursing staff’s assessments, rather than the subject’s assessments.

    View the original warning letter.


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  4. Warning Letter: Hospital stretcher manufacturer failed to validate computer software (ucm 355751)

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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). Specifically, [redacted], developed by [redacted], is used to transfer and make changes to drawings used to manufacture devices. There is no protocol or documentation demonstrating that this software has been validated for its intended use.

    View the original warning letter.


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  5. Warning Letter: Failed to exercise appropriate controls (ucm 355294)

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    Additionally, during an audit of the data submitted in support of the [redacted] regarding [redacted] tablets USP [redacted] mg, our investigator requested to review the electronic analytical raw data to compare the values for [redacted] assay and degradation products. However, your firm provided only the printed copies of the raw data because your firm did not have the software program available to view the electronic raw data.
    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)).

    During the inspection, our investigator also identified a backdated QC worksheet in the analytical report of [redacted] API raw material batch [redacted]. When your analyst affixed the related substance and IR weight printouts to the Format for Blank Sheet for Printout (Format No. F2/QCD/F/026-00), he signed and dated this worksheet as July 29, 2011. A second analyst, who reviewed this worksheet, also signed and dated it as July 29, 2011. However, your QA department did not issue this worksheet until July 31, 2011. Your analyst acknowledged during the inspection that he backdated this worksheet on July 31, 2011.

    Your response stated that the analyst incorrectly dated the worksheet as July 29, 2011, instead of July 31, 2011, and that there was no intention to deliberately backdate the document. However, your response contradicted your analyst’s backdating admittance during the inspection. In addition, your response did not explain the reviewer’s signature which was also dated July 29, 2011.
    Backdating documents is an unacceptable practice and raises doubt about the validity of your firm’s records.
    View the original warning letter.


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  6. Warning Letter: Failure to implement software upgrade (ucm 352318)

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    CAPA [redacted] was opened on May 25, 2011 to address Plum A+ pump battery failures which can cause a delay or interruption of critical therapy. Your firm has failed to  implement the identified corrective actions in this CAPA, such as a software upgrade to change the risk profile; battery replacement to reduce the probability of occurrence; battery supplier approval with increased controls; and notification to customers, despite the fact that your firm has received 311 complaints for code E321 documenting battery failures and 11 MDRs documenting a stoppage of critical drug delivery as of January 31, 2013. Plum A+ infusion pump: Review of the “analysis” data field for Plum A+ complaints revealed failures of the bubble sensor printed wire assembly within the printed circuit board, battery, touch key pad assembly and front case assembly.

    In addition, the failed components are not identified as a data source for analysis nor are they trended in your CAPA system to assess whether a preventive or corrective action is indicated and to ensure that components are performing according to infusion pump design specifications.

    View the original warning letter.


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  7. Warning Letter: Failure to document changes (ucm 348651)

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    During our inspection, a Red Blood Cell component was identified as being in quarantine according to an electronic inventory inquiry on January 30, 2013. However, the component could not be located in the expected physical quarantine location. After the discrepancy was identified by our investigators, a search was initiated and the component was found in the discard bin. The component had been physically discarded without maintaining a record of the discard as required by TS 500-2, Final Disposition of Blood Components. Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)].

    View the original warning letter.


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  8. Warning Letter: Labeling software is not defined in SOP (ucm 352769)

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    Your firm’s product labeling procedure has not been adequately implemented as required by 21 CFR § 820.120. Specifically, you lack documented approval for your vacuum therapy device; labeling software is not defined in your standard operation procedure; and device history records lack the primary label/labeling.

    View the original warning letter.


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  9. Warning Letter: eCRF lacks laboratory values (ucm340269)

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    As an investigator, you are responsible for maintaining accurate, complete, and current records relating to the investigation. (See 21 CFR 812.140(a)). You failed to adhere to the above-stated regulations. Examples of these failures include, but are not limited to the following: a. (b)(6) • The Electronic Case Report Form (eCRF) lacks baseline vital signs, permanent pacemaker) interrogation findings, or laboratory values.

    View the original warning letter.


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  10. Warning Letter: Failure to follow procedure (ucm342736)

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    Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example, the design control procedure (P03 02) requires that design reviews be completed at the end of the completion of all technical documentation. The design review for the Lady Comp device was completed June 16, 2008, prior to the completion of the software qualification for the Lady Comp device, which was completed October 17, 2008. No design review was conducted after the software qualification. The adequacy of your firm’s response, dated October 26, 2012, cannot be determined at this time. Your firm completed a new design review for the Lady Comp device that included software validation. Additionally, your firm stated that training would be conducted on the current design review procedure. However, the evidence of implementation to include the training documentation was not provided in the response.

    View the original warning letter.


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