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  • FDA Warning Letters


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    1. Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

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      “Failure to establish and maintain procedures to control all documents, as required by 21 CFR
      820.40. For example, your firm failed to follow its Documentation Management procedure since it
      used electronic signatures to approve numerous procedures. Your firm’s procedure states that
      there are no currently-approved electronic signature systems implemented at your firm.”

      View the original warning letter.


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    2. Warning Letter: Failure to document digital changes and complaints (ucm421235)

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      No records of identification, validation or verification, review, or approval were available for design changes to the SimulCare resulting in the SimulCare II. The changes included new digital controls… Failure to ensure that suppliers and contractors were evaluated and selected based upon their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm utilizes various suppliers for components of your devices, including PCBs [Printed Circuit Boards]…your firm failed to record and document investigation of oral complaints related to burnt-out microchips… Specifically, the SimulCare II was cleared under K083202; however, your firm’s promotion of the device provides evidence that the device was modified including a change from analog knobs utilized to control the strength and duration of therapy to digital button controls now utilized for the same function.

      View the original warning letter.


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    3. Warning Letter: Failure to have proper controls (ucm421988)

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      Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.

      Your firm did not have proper controls in place to prevent manipulation of your laboratory’s electronic raw data. Specifically, your NuCon 5700 gas chromatographs (GCs) did not have access controls that would prevent the deletion or altering of raw data files. In addition, the GC software lacked active audit trail functions to record any changes to the data, including the previous entries, who made the changes, and when the changes were made. The use of audit trails for computerized analytical instrumentation is essential to ensure the integrity and reliability of the electronic data generated.

      During the inspection, your management explained that the laboratory practice was to delete the raw data files once the chromatograms were printed. As such, your firm did not retain complete raw data from testing to ensure the quality of your APIs. Specifically, electronic raw data files, supporting your GC testing for release (assay) were deleted.

      Failure to have appropriate controls for issuance of batch records.

      Our inspection found that batch records were uncontrolled in that operators had the ability to print batch records from their personal computers. In addition, various uncontrolled blank manufacturing batch records were found in a binder located in the production office.

      View the original warning letter.


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    4. Warning Letter: Complaints closed without investigation (ucm42084)

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      Your firm’s CAPA trending of production hardware failure non-conformances is inadequate in that 39 production hardware failure non-conformances reviewed found you stated a justification for not opening a CAPA for each of these non-conformances as “NCMRs are trended periodically and CAPAs are issued according to this trending.”

      View the original warning letter.


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    5. Warning Letter: Procedure not implemented (ucm416625)

      Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established, as required by 21 CFR 820.50. Specifically,

      a. Your firm has not defined and documented the specific requirements and specifications to be met by your suppliers of audiometer device components such as speakers and keypad membranes.

      b. Your Vendor Qualification SOP #E-001, Rev A, has not been implemented. Section 5.3 requires audits of vendors of custom components and services, unless they have received ISO registration and a copy of the ISO registration is obtained. Your firm has not performed audits of custom device components such as the keypad membrane and the firmware, and there is no ISO registration for those firms on file.

      View the original warning letter.


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    6. Statement of Non-Compliance with GMP (from Italian Medicines Agency)

      • Reached the conclusion that fundamental GMP and regulatory requirements such as loss of data integrity, combined with insufficient management of data, change control system, supplier qualification, laboratory controls as well as the accuracy of data submitted, were not adequately implemented/considered…
      • Severe GMP violations related to the implementation of sound computerised systems in the quality control facilities were committed, that could lead/could have led to the falsification of data.

      View the original Statement of Non-Compliance


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    7. Warning Letter: Inadequate validation (ucm408746)

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      Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, your firm’s software validation testing for the Qube compact monitor (part number 91390) was conducted according to Design Validation Plan 91390 Salish Compact Monitor,819-0011-00, Rev. A, for the English and foreign language packs. There were multiple test case failures, yet your firm reported in Design Validation Report, 816-0099-02, that “the test results showed the product is acceptable and it meets the user requirements for patient monitoring.”…Your firm did not submit a current adequate validation for the software cited for the Qube compact monitor.

      View the original warning letter.


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    8. Warning Letter: Inadequate spreadsheet (ucm406826)

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      Also, your firm tracks complaint data on a spreadsheet that contains free form text fields that are not standardized, resulting in an inability to adequately trend the data. For example, when using complaint data from January 1, 2011 to February 19, 2014 to trend for “Description of Failure” for “6090,” fourteen complaints are shown. However, the spreadsheet contains several different descriptions of the same part failure that when totaled resulted in a total count of forty complaints related to the inline coupler, part #6090.”

      View the original warning letter.


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    9. Warning Letter: Lack of spreadsheet control (ucm404316)

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      Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management.

      Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted all electronic raw data supporting your high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. In addition, your firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. Your firm’s lack of data control causes us to question the reliability of your data.

      View the original warning letter.


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    10. Warning Letter: Failure to follow SOP/Lack of controls (ucm401451)

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      1. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

      Your firm lacked accurate raw laboratory data records for API batches shipped by your firm. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, your quality control (QC) laboratory failed to include complete data on QC testing sheets. Failing or otherwise atypical results were not included in the official laboratory control records, not reported, and not investigated.

      Your firm’s response to the Form FDA-483 acknowledges the deficiencies regarding data integrity observed during this inspection. Nevertheless, your firm’s health hazard evaluation “Drug Safety Analysis” conducted in response to the Form FDA-483 concluded that there was no effect on product quality or patient safety. However, this evaluation was based on unreliable and incomplete data, as undesired records appear to be excluded. For instance, your report failed to include all of the batches tested, and did not list all of the customers you notified other than Apotex, Inc. Your response to the previous 2010 inspectional findings stated that “We are confident that … SOPs covering OOS … and Deviation … will provide the necessary control over the system to ensure consistent application and on-going compliance to this requirement.” However, you clearly failed to detect and investigate the inaccurate data found by our investigators during this recent inspection.

       

      View the original warning letter.


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