Week of October 14th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters this week including:

  • 1 issued to a pharmaceutical company in South Korea
  • 1 issued to a clinical trial investigator in California


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  • Ignatius P Godoy, M.D. (Paramount, CA) receive a warning letter based on the outcome of a BIMO inspection for a clinical study ending June 8th 2018. The study in question was a Phase 3 evaluation of an influenza virus vaccine in a pediatric population.
    • Subjects were enrolled in the study, but no documents (including informed consent) exist for these subjects.
    • Study subjects were enrolled even though they met exclusion criteria. The investigator failed to follow protocol recommended guidelines in randomization of subjects. Subjects were being treated with immunosuppressive therapies which should have excluded them from the study.
    • Vaccine was administered to study subjects even though the vaccine had been subject to a temperature excursion during storage.
    • Discrepancies were evident between source documents and case report forms regarding the day 3-5 phone calls. Informed consent forms were either not maintained properly or were not documented appropriately.


  • Hanlin Pharm Co., Ltd (Seocho-Dong, South Korea) received a warning letter on October 3rd 2018 based on the outcome of an inspection ending February 6th 2018. The firm was placed on import alert on May 3rd 2018. FDA recommends that the firm retain qualified consultant(s) to assist them in coming into GMP compliance.
    • Aseptic practices during set up and filling were deficient. In response to the warning letter, the firm is asked to provide:
      • “Your plan to assure strict adherence to appropriate aseptic practices and cleanroom behaviors. Specify how your firm will ensure routine and effective supervisory oversight during manufacture of each batch. Also, describe the frequency of quality assurance oversight, such as audits, during aseptic processing and other operations.
      • A thorough risk assessment that evaluates how poor aseptic technique and cleanroom behavior such as that observed during the inspection may have affected quality and sterility of your drugs. 
      • Comprehensive, independent identification of all contamination hazards specific to your aseptic processes, equipment, and facilities. Provide an independent risk assessment that covers, among other things, all human interactions with the ISO-5 area, equipment placement and ergonomics, air quality in the ISO-5 area and surrounding room, facility layout, personnel flow, and material flow.
      • A detailed corrective action and preventive action (CAPA) plan, with timelines, to address the findings of the contamination hazards risk assessment. Describe how you will significantly improve aseptic processing operation design, control, maintenance, and personnel qualification.”
    • Environmental monitoring did not include routine monitoring of viable organisms, nor was personnel monitoring of individuals conducted. In response to the warning letter, the firm is asked to provide:
      • “A comprehensive assessment and CAPA plan for your environmental monitoring program (including personnel monitoring) to ensure it supports robust environmental control of your aseptic processing facility. Your assessment should include justification of sampling locations, frequency of sampling, alert and action limits, the adequacy of your sampling techniques, and trending program.”
    • Laboratory records do not include complete data derived from all tests. Staff were observed backdating results, and some results were recorded prior to evaluating test results. Staff were not aware of Good Documentation Practices requirements. In response to the warning letter, the firm is asked to provide: “Your CAPA plan as requested in the Data Integrity Remediation section of this letter below.” This includes the 3-part standard boiler-plate text found in many warning letters.
    • The firm did not have adequate controls over computer systems in place. For example, 3 QC team leads had administrator privileges for HPLC systems.  Two systems did not have the date/time function locked, and, thus, staff could change the date and time. Similar deficiencies were found during the 2016 inspection.


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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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