FDA Warning Letters


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  1. Warning Letter: Failure to validate/Insufficient Controls (s6630c)

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    Failure to have a validated and secure computerized system. Additionally, there were no written protocols to assign levels of responsibilities for the system. It was noted that the [redacted] instrument model [redacted] used for the analysis of [redacted] failed to have password control for the analysts and the supervisor. It was observed that the data stored on the computer can be deleted, removed, transferred, renamed or altered. While your firm’s management stated that they would like to implement certain improvements in order to establish a security system, no documentation or commitment has been provided. Please note that computerized systems should have sufficient controls to prevent unauthorized access or changes to data. There should be controls to prevent data omissions and assure back-up. There should be a record of any data change made, the previous entry, who made the change, and when the change was made.

    View the original warning letter.


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  2. Warning Letter: No documentation of employee training (s6597c)

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    Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b). For example, there is no documentation of any training of any current employees with regard to their assigned responsibilities, although your training procedures require documentation of training. … Failure to conduct quality audits; and failure to implement audit procedures to assure that the quality system is in compliance with the established quality systems requirements and to determine the effectiveness of the Quality Systems, as required by 21 CFR § 820.22.

    View the original warning letter.


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  3. Warning Letter: Failure to validate processes (ucm076566)

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    Failure to validate manufacturing processes and approve according to established procedures, where the results cannot be fully verified by subsequent inspections and tests. [21 C.F.R. 820.75(a)] Specifically: Computer Numerical Control (CNC) Machine #C-4 had out of specification results during operational qualification conducted during validation. These out of specification results were not investigated or addressed in the validation report.

    View the original warning letter.


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  4. Warning Letter: Failure to validate computer software (s6537c)

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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: For yours, Asheboro, NC, facility, the [redacted] Training Database software validation used to document employee training was deficient in that the test scripts were not available to show the execution of the software validation protocol. It appears that at least five (5) tests specified in the approved protocol were not performed.”

    View the original warning letter.


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  5. Warning Letter: Employees not adequately trained (ucm076532)

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    Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). For example: “a. Training records for a sterilizer operator and packager were requested at your Asheboro, NC, facility during the 2007 FDA inspection. Out of five (5) training records requested for the sterilizer operator, only two (2) were available. Two (2) training records were requested for the packager and only one (1) record was available.” “b. A number of documents were collected demonstrating that employees were not adequately trained, at your [redacted] facility.

    View the original warning letter.


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  6. Warning Letter: Failure to maintain records (s6526c)

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    Failure to maintain accurate, complete, and current records of each subject’s case history and exposure to the device [21 CFR 812.140(a)(3)].” “We also note that according to Ms. Little-Tierney, all of the original medical records involved in this study were discarded after they were scanned. Your response to the FDA 483 indicates that your medical practice normally operates as a [redacted] office, relying on [redacted] copies of records. Any [redacted] records you maintain must be sufficient to meet your underlying recordkeeping obligations. As we noted above, as an investigator, you are required to maintain accurate, complete, and current records as provided for in 21 CFR 812.140 (a). You must maintain all required records for a period of two years after the latter of the following two dates: the date on which the investigation is terminated or completed, or the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol. (See 21 CFR 812.140(d)).

    View the original warning letter.


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  7. Warning Letter: Computer systems not validated (s6381c)

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    "Software used as part of the production quality system
    was not validated
    for its intended use according to an established protocol [21 C.F.R. 820.70(i)]. Specifically,
     
    (a)
    Spreadsheets
    intended to check for outliers and calculate mean, SC, % CV, value assignments for finished devices.
    (b) Complaint handling software
    (c) Quantrol database program"

     

    View the original warning letter.


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  8. Warning Letter: Failure to Validate MS Excel Spreadsheets (s6366c)

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    Failure to adequately validate the intended use of this PC and its software, as required by 21 CFR 820.70(i). “For example: the dedicated PC [redacted] attached to the [redacted] was not secure in that access to the data on [redacted] was not granted by a unique username and password or equivalent method; there as no documentation associated with the electronic data for whom was responsible for collection of the analytical results as several quality control personnel have access to the [redacted] no software changes in the study data could be detected as there was no audit trail capability ; and finally, the electronic data did not correlate with the paper records.”

    View the original warning letter.


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  9. Warning Letter: Failure to validate computer software (s6338c)

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    Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, electronic records are used, but there was no software validation. No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software used in creating and maintaining nonconformance records, product return records, internal audit corrective action records, or preventive action records. View the original warning letter.


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  10. Warning Letter: Failure to validate before implementation (s6328c)

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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 their implementation, as required by 21 CFR 820.30(i). Specifically: a) In June 2006, your firm recalled 2455 units of the Spectrum Infusion Pump due to several events where the pump tubing mis-loaded when it was installed by the end user. Several design changes were made to the Spectrum Pump's hardware and software to better assist the end user in installing the pump tubing. These design changes were incorporated into the blanket Engineering Change Notice (ECN # 15501). This ECN contained several individual ECNs to cover each change that was made to correct the tubing mis-loading problem. However, the blanket ECN also included an individual ECN to implement the PCA/PCEA delivery modes within the Spectrum pump. ECN# 15501 and all individual ECNs under this blanket ECN were cleared for manufacturing on May 01, 2006. However, our inspection revealed the
    software verification/validation
    for the pump operating software version 4.00.04 and MDL software version 5, and the design of the hardware components associated with the PCA/PCEA module were not completed at the time the re-designed Spectrum pump was released for manufacturing. Yet, ECN # 15501 was approved for manufacturing by your firm's Approval Committee (consisting of representatives from Engineering, Manufacturing, Quality Assurance and Purchasing), without ensuring that the appropriate verification/validation for the PCA/PCEA functions were completed. More significantly, 257 units of the Spectrum pumps, manufactured between May 01, 2006, and June 26, 2006, were distributed into interstate commerce with an "enabled" version of this unvalidated PCA/PCEA function as replacements for defective devices that were returned to Sigma International as a result of the June 2006 recall."

    View the original warning letter.


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