Week of June 3rd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA warned 9 firms that operate a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. FDA reminds the public that no one is authorized to sell or distribute opioids via the internet, with or without a prescription. A total of 17 warning letters were posted this week. We cover 3 of them below.


  • The Fertility Partnership LLC (Peters, MO) received a warning letter on May 24th 2018 based on the outcome of an inspection ending March 5th 2018. The warning letter focuses on failures in basic safety aspects of these products. The time between the end of the inspection and the issuance of the warning letter was very short — indicating the extent of likely public health harm this firm posed. Deficiencies include but are not limited to:
    • Failure to adequately evaluate medical records and test donor tissue for evidence of infection or communicable disease.
    • Failure to test using FDA-licensed or approved or cleared in vitro screening tests.
    • Failure to maintain records that include a unique identification code to relate the record to a donor.
    • Failure to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility.
  • Further FDA states: We are concerned about your ability to correct the violations noted above and prevent their recurrence. We acknowledge the voluntary suspension of your establishment’s operations on multiple occasions to correct similar violations noted during inspections. However, deviations have recurred despite your attempts to correct them during these voluntary suspensions. In addition, your response indicated that you recently had a “significant turnover in staffing” and we continue to be concerned about your ability to effect corrective actions after expanding your operations.”

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  • IDT Australia Ltd (Victoria, Australia) received a warning letter on May 23rd 2018 based on the outcome of an inspection ending December 8th 2017. The firm manufactures for APIs and finished dosage forms. FDA requests that the firm schedule a regulatory meeting with FDA. Deficiencies include but are not limited to:
    • API: Failure to implement corrective actions in a timely manner. FDA provides as example where the firm did not implement a corrective action 2 years after the OOS event. FDA asks the firm to provide:
      • “…an action plan with timeframes for a global assessment of your corrective actions performed over the past three years. Ensure this assessment identifies all investigations and the corrective actions and preventive actions that you initiated in response to your investigation findings, and that it shows how you determined that you expanded your investigations to other potentially affected batches.”
    • API: The Quality Unit released a batch of API that exceeded the total aerobic count specifications to a firm on the US that manufactures sterile finished drug products. FDA asks the firm provide:
      • “…assess the risks of your decision to release batch (b)(4) despite the microbiological test failure and despite the inadequacy of your investigation into the cause of the failure. Provide your plans for addressing product quality and patient safety risks for any drugs still in distribution, including potential recalls or market withdrawals. Provide an updated OOS procedure that requires the speciation of microbes found as a result of any microbial analysis.”
    • FINISHED DRUG: The firm reported microbial test results as “> 80 CFU” when the actual result was TNTC. Days later the firm resampled and diluted the new sample to a level where colonies could be counted. If these values met specifications, the earlier failing results were discarded. FDA is concerned that sample collection and test methods could have masked filing results. FDA asks the firm to provide:
      • “… the scientific rationale for your modified (b)(4) sample collection and test methods. In addition, assess the product quality and safety risks of using potentially contaminated (b)(4).”
    • Laboratory records did not include complete data from all tests. The firm failed to report ‘non-conforming’ results multiple times, and FDA provides examples.
    • The Quality Unit did not review HPLC data used for release and stability assessments of product. At issue are at least 100 ‘test’ injections that are not addressed in either procedures or methods. Further, analysts performed manual integration without inspections as to when that is permitted and how it is to be performed. And, finally, the firm does not have procedures for review of audit trails or electronic data for the FTIR and UV systems.
    • FDA also provides the ‘long version’ of their data integrity remediation boilerplate for the firm to address.
  • Kolmar Corea Co Ltd (Sejong-si, South Korea) received a warning letter on May 18th 2018 based on the outcome of an inspection ending September 28th 2017. The firm manufactures final dosage forms of OTC products. Deficiencies include but are not limited to:
    • The firm did not investigate OOS results, but simply retested and invalidated the OOS results. FDA recommends reading the OOS Guidance. The firm is asked to provide the following in response to the warning letter:
      • “… a summary report on the retrospective review of all invalidated OOS results obtained for products distributed to the U.S. market. If your investigation reveals that you released drug products that did not meet specifications, indicate the corrective actions you have taken or will take, such as notifying customers or recalling products.”
    • The quality unit is required to give approval before the discarding of documents and records. This firm did not follow this requirement in their procedures. In response to the warning letter the firm is to provide:
      • “A detailed plan for evaluating the effectiveness of your training program.
      • A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates documentation practices, and ensures you retain complete and accurate records.” 

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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