Remediation for Specific Issues


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  1. Warning Letter: Failure to establish procedures (ucm165301)

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    Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.

    View the original warning letter.


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  2. Warning Letter: Failure to maintain quality system requirements (ucm152423)

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    Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 21 C.F.R. § 820.20(b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements. Additionally, you stated that your quality system has not kept pace with the growth of your firm’s business.

    View the original warning letter.


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  3. Warning Letter: Failure establish and maintain records (ucm166530)

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    Failure to evaluate and select suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 C.F.R. 820.50(a)(1). 17) Failure to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a)(3).

    View the original warning letter.


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  4. Warning Letter: Lack of controls and audit trails (ucm1048180)

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    The [redacted] data acquisition system for the [redacted] UV/Visible spectrophotometers allows your analysts to modify, overwrite, and delete original raw data files. The spectrophotometers are used for dissolution testing of finished product, stability samples, and process and method validation studies. All laboratory personnel were given roles as [redacted] Managers, which allowed them to modify, delete, and overwrite results files. This system also does not include an audit trail or any history of revisions that would record any modification or deletion of raw data or files. Your laboratory computer system lacks necessary controls to ensure that data is protected from tampering, and it also lacks audit trail capabilities to detect data that could be potentially compromised.”

    View the original warning letter.


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  5. Warning Letter: Failure to Comply (s6876c)

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    • Failure to adequately validate manufacturing processes with a high degree of assurance, and approve and document the results of the validation activities, to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not validated the milling process and documented the validation results to ensure that the brass rounds are correctly milled to patients’ programmed [redacted] files [redacted] codes).
    • Failure to revalidate manufacturing processes in response to changes or process deviations, and document the results of the revalidation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(c). Specifically, your firm has not documented the results of the revalidation of the milling process after your firm repaired a loosened bushing on the tooling plate and [redacted] without established procedures in place for implementing these changes.
    • Failure to establish and maintain procedures for verifying or validating, approving, and documenting changes to a specification, method, process, or procedure, before implementation, as required by 21 C.F.R. § 820.70(b). Specifically, your firm has not established written procedures describing how changes to your milling process are to be verified or validated, approved, and documented.

     

    View the original warning letter.


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  6. Warning Letter: Failure to record in audit trail (ucm076260)

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    On January 11, 2006, during content uniformity testing of[redacted], the analyst noticed that the first two capsules were out-of-specification

    and the run was aborted. The audit trail for the laboratory data acquisition system does not indicate that the run was aborted and the analyst did not print the sample results or record the failing results in the laboratory notebook.

    View the original warning letter.


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  • Warning Letter: Failure to indicate reason for change (ucm075728 )

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    Failure to indicate the reason for change in automated data entries [21 CFR 58.130(e)]. In several instances, entries in the [redacted] collection/notes and audit trails failed to provide the reason for changing raw data. For example, audit trail entries for study [redacted]demonstrate that observations of “normal” were removed without an explanation.

    View the original warning letter.


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  • Warning Letter: Failure to follow 21 CFR 11 compliance (g5276d)

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    Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr.  [redacted] that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you to Mr. [redacted], dated January 31, 2005, detailed the name of the EMR system and the means by which study subject information is entered. Please note that Title 21, Code of Federal Regulations, Part 11, “Electronic Records; Electronic Signatures ” outlines specific requirements that must be met for any system that is being used to maintain required records. In addition to the information requested above, please submit the following:

    • Documentation of the validation of your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records;
    • Documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency;
    • Documentation of a secure, computer-generated, time-stamped audit trail that can independently record the date and time of operator entries and actions that create, modify, or delete electronic records, and to verify that record changes do not obscure previously recorded information.

    View the original warning letter.


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  • Warning Letter: Incomplete requirements (ucm075276)

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    Your firm failed to address design input requirements that are incomplete, as required by 21 CFR 820.30(c) [FDA-483, Item 31. Specifically,

    • Functional requirements for the DBSS are in some cases very high level. For example, the requirements for Donor Reporting merely state that the application must enable the user to identify, from a list of persons, the donor on whom the report should be based, and to print an Autologous Unit Status Report, a Donor History Report, a Person Audit Trail Report, a Deferral Audit Trail Report, and an Individual Donor Orders Report for a specific donor. The requirements do not address the files to be accessed, the fields to be printed, or the format of the ave been written for problems with these reports. [redacted] have been written for problems with these reports. For example, [redacted] concerns the military personnel’s SSN appearing where the donor’s SSN should appear on the Donor Audit Trail Report.”

    View the original warning letter.


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  • 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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