FDA Warning Letters


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  1. 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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  2. 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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  3. 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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  4. 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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  5. Warning Letter: Failure to follow SOP/Lack of controls (ucm401451)

    Tags: |

    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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  6. Warning Letter: Failure to adequately validate software (ucm399011)

    Tags: | |

    Failure to adequately validate software used as part of production and the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, actions were not taken to ensure that computer errors would not result in the loss of dosimetry and run dose data from the Dosimetry Measurement Application (DMA) module of [redacted].

    View the original warning letter.


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  7. Warning Letter: Failure to perform validation of device software (ucm402449)

    Tags: |

    Failure to perform validation of device software, as required by 21 CFR § 820.30(g). Specifically, your firm failed to validate the software calculator for the STAAR Visian MICL Lens (ICL models MICL 12.1 mm, MICL 12.6 mm, MICL 13.2 mm, MICL 13.7 mm).

    View the original warning letter.


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  8. Warning Letter: Failure to capture electronic data (ucm399364)

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    AMKS TRL monitoring failed to identify and correct a clinical investigator’s failure to collect study subjects’ data on protocol-specific case report forms (CRFs), as required by Protocol [redacted]. We note that during the inspection, you indicated that AMKS TRL did not use any paper CRFs or electronic data capture to record study subjects’ data.

    View the original warning letter.

     

     


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  9. Warning Letter: Failure to validate software (ucm399525)

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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, your firm’s [redacted] Software Operating System used to log, evaluate, and investigate complaints, incoming, in process, and finished non-conformances was not validated to prevent deletions of records by employees.

    View the original warning letter


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  10. Warning Letter: Mishandling and retrieval of electronic data (ucm393093)

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    Your firm failed to establish SOPs describing the handling and retrieval of electronic data. Handling of electronic data includes the security (e.g., audit trails) and statistical analysis of raw data. Specifically, the SOP for handling electronic data should describe a procedure for the archiving of multiple statistical analyses of the clinical pathology raw data with the study records. For Study [redacted], multiple sets of statistical analyses were maintained on the firm’s electronic server, and were not archived appropriately.

    View the original warning letter.


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