FDA Warning Letters


  1. Warning Letter: Software has not been validated (ucm227058)

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    The [redacted] Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.

    View the original warning letter.


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  2. Warning Letter: Failure to establish procedures (ucm224014)

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    Failure to establish and maintain adequate procedures for verifying or validating 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, no protocol, including acceptance criteria, was established for the validation of Change Request [redacted]. Additionally, there was no documentation showing that this change was validated.

    View the original warning letter.


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  3. Warning Letter: Incomplete validation (ucm223938)

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    Your validation procedure describes your acceptance criteria and states [redacted]. However, your validation report does not address [redacted]. In addition, your testing described in your Validation Protocol [redacted] does not account for detection of [redacted]. Your validation data and results should ensure that all your acceptance criteria are met. In addition, your microbiological results provided with your response do not indicate whether the results reflect [redacted].

    View the original warning letter.


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  4. Warning Letter: Failure to Follow Procedures (ucm216889)

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    Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure [21 C.F.R. § 820.75(a)]. “Specifically, the procedure “Validation of the Aseptic Filling Process Utilizing the Media Fill Method,”[redacted], states that initial validations should be conducted consecutively and prior to routine production fills and subsequent re-qualifications should be performed [redacted] as appropriate. In addition, the procedure states that routine production may not resume until acceptable qualification or validation runs are achieved or until all appropriate investigations and/or repeat media fills have been performed with acceptable results. However, validation of the aseptic filling process in filling suite [redacted] for [redacted] bottles was inadequate in that the [redacted] re-qualification of the [redacted] Aseptic Filling Process utilizing the Media Fill Method [redacted]performed on March 23, 2009 failed. The failure produced [redacted] contaminated units out of approximately [redacted] units inspected. In addition, the subsequent validation of [redacted] for filling [redacted]and [redacted] bottle [redacted performed on May 20, 2009 also failed.

    View the original warning letter.


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  5. Warning Letter: Failure to validate after design changes (ucm217812)

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    Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before there implementation as required by 21 CFR § 820.30(i). Specifically, your firm’s design change request form and design change review form included with your CSO Design Change procedure (procedure includes no signature and date of approval for implementation and no revision history) does not require validation or verification of design changes before there implementation. Your firm has failed to ensure that after the design requirements are established and approved, changes to the design,
    both pre-production and post-production are also validated (or verified where appropriate), and approved before implementation.

    View the original warning lettter.


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  6. Warning Letter: Failure to validate software (ucm215449)

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    In addition, FDA noted nonconformance with regards to section 501(h) of the Act, 21 U.S.C. 351(h), due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part at 21 C.F.R. Part 820. These deviations include, but are not limited to, the following:

    • Failure to validate the device software for the RTVue OCT with NDB, software versions 3.5 and 4.0 as required by 21 CFR 820.30(g). Specifically: “a. Software 3.5 Version C, was tested between [redacted]. The test result shows a failure with sequence [redacted]. The failure was identified as [redacted], unreasonable video baseline, known “bug”.
    • Verification and Validation for Version D was approved on [redacted] to address the test result identified from the testing of software Version Verification and Validation testing was performed on software 3.5 Version D, on [redacted]. The report identifies a “Remaining Defect List” and Number [redacted] is identified as “Critical”, “Spectrometer Motor Error!” This software version was released on [redacted] without addressing defect number [redacted] and without supporting documentation software defect number [redacted] was corrected.
    • Verification and Validation test results/raw data for software 4.0, Version B, were performed on [redacted] and [redacted]. Sections of the test data were not performed, unsigned, and/or missing as follows: I. Section 16 – Cornea Module, not performed. II. Section 11 – Gridline Examine and Analyze, not performed. III. Section 10.2 – Verify [redacted] new function, unsigned and undated. IV. Section 15 – Combined Progression of [redacted] and [redacted] scans, a test sequence was not performed. V. Unidentified Section, raw test data missing. This test section is signed-off by an employee, with a completion date of [redacted].
    •  Electronic sign-off copy of the Verification and Validation Report for software 4.0, Version B. found the following: I. Section 16 – all sequence is entered as pass without supporting data to demonstrate the test was performed. II. Section 11 – all sequence entered as pass without supporting data to demonstrate the test was performed. III. Section 10.2 – contains an electronic signature of an employee, dated [redacted] IV. Section 15 – all sequence entered as pass without supporting data to demonstrate the test was performed. V. Section 3.1 – Verify Calibration Data is entered as being completed on [redacted] There is no supporting data to demonstrate sequence testing was performed. However, the last sequence test page of this test section is identical to a test performed by an employee on [redacted], not [redacted] as entered into the firm’s electronic sign-off copy.
    • Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed.

    View the original warning letter.


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  7. Warning Letter: No Procedures for Controlling Worksheets (ucm218221)

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    Your firm has no procedures for controlling laboratory worksheets including changes to worksheets, issuance of laboratory worksheets, and reconciliation of laboratory worksheets. The worksheet “Internal Communication – Batch Release Information” by the warehouse, which is used to identify released product, was created after [redacted] documented release of finished product for Heparin I.V. Flush Syringes and Normal Saline I.V. Flush Syringes prior to obtaining media fill results. This sheet is used to communicate batch release information to warehouse operations. Use of this sheet is not documented in any Medefil procedure nor is control over this sheet documented.

    View the original warning letter.


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  8. Warning Letter: Failure to establish procedures (ucm216937)

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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). For example, your firm opened CAPAs in response to quality audit data which showed the lack of QS regulation training in many departments within your firm. However, the CAPAs do not contain or reference documentation to support complete implementation of the CAPA activities, such as investigating the cause of the nonconformity, identifying the action needed to correct and prevent recurrence, and verification or validation of the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as defined in your firm’s Corrective & Preventive Action Procedure QSR-115.

    View the original warning letter.


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  9. Warning Letter: Failed to validate input/output (ucm214564)

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    Your firm failed to check the accuracy of the input to and output from the computer or related systems of formulas or other records or data and establish the degree and frequency of input/output verifications. For example, the performance qualification of your [redacted] system software (Validation No. 4000-03-PQ-0002) failed to include verification of the expiration date calculations in the [redacted] system. In addition, there is no established degree and frequency of performing the verification. Discrepancy reports have documented that product labeling with incorrect expiration dates have been created and issued for use.

    View the original warning letter.


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  10. Warning Letter: Uncontrolled spreadsheets (ucm227896)

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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)].

    • Your firm’s laboratory analysts have the ability to access and delete raw chromatographic data located on the [redacted] of [redacted] used to conduct HPLC testing. Due to this unrestrictive access, there is no assurance that laboratory records and raw data are accurate and valid.
    • Your firm’s laboratory analysts have the ability to access and modify the  formulas in the Excel spreadsheets  used to calculate assay results for Guaifenesin and [redacted] drug products. Due to this unrestricted access, there is  no assurance that the formulas in the Excel spreadsheets are accurate and valid.

    View the original warning letter.


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