Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 warning letters this week including:

  • A collection from the Center for Tobacco Products
  • 1 to a PET firm
  • 1 to a device firm
  • 1 to a compounding pharmacy


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  • Datascope Corporation (Fairfield, NJ) received a warning letter on September 11th 2018 based on the outcome of an inspection ending June 11th 2018. The firm manufactures intra-aortic balloon catheters and cardiopulmonary bypass pumping packs. Deficiencies include but are not limited to:
    • Supplier controls are not adequate as shown by the supplier’s expanded recall based on Datascope Corporations’ complaints. The firm does not adequately select suppliers who can meet specified requirements including qualify requirements.   
    • The firm failed to adequately validate changes made to product packaging. These changes resulted in customer complaints.
    • Further, the warning letter identifies 3 deficiencies such that the products are deemed misbranded.


  • N-Molecular In dba SOFIE (Culver City, CA) received a warning letter on September 24th 2018 based on the outcome of an inspection ending February 28th 2018. The firm manufactures positron emission tomography (PET) drugs. Deficiencies include but are not limited to:
    • A sterility failure investigation was not complete and was not approved for over a year and a half. There was no root cause identified and no corrective actions were put in place. In response to this letter, the firm is asked to provide:
      • “A thorough assessment of the adequacy of your facility, equipment, and process (including both production and testing laboratory) design and controls.
      • A comprehensive corrective action and preventive action (CAPA) plan that identifies microbial contamination risks throughout your operations and describes improvements to assure higher confidence in the sterility of products made at your facilities.
      • A revised cleaning and disinfection program that ensures an environment suitable for aseptic processing and sterility testing.
      • An assessment of your overall system for investigations into deviations, discrepancies, complaints, OOS results, failures, and verification of effectiveness of corrections. Include an action plan to fully remediate this system throughout your company’s network.”
    • The facility was in poor repair and lacked cleanliness. The firm is asked to provide the following as part of the warning letter response:
      • “Your alert and action levels for ISO 5 surfaces, air, and operator gloves, and improved procedures that address appropriate responses to contamination at these levels.
      • Your investigations for any recovery of microbes in ISO 5 hoods and on operator gloves, and any results outside alert or action levels for the ISO 7 environment since January 2017. Also include all organism identifications performed for these two clean areas during this period, and the location where microbes were recovered.
      • Evidence that cleaning and disinfecting agents used in all classified areas are effective.
      • Your firm’s procedures for ensuring ongoing maintenance and control of your facility.”
    • Manufacturing changes were not properly managed, nor was a sterile filtration change validated. In response to this letter, firm was asked to provide:
      • “Your procedures to evaluate all production and testing changes prior to implementation, including specific steps to ensure appropriate technical evaluation.
      • A retrospective analysis to determine whether any other changes, particularly changes related to aseptic processing and sterility assurance, were implemented without adequate change management, and determine whether they adversely affected the quality of your PET drugs.”


  • Innovative Intrathecal Solutions Inc. dba Innovative Compounding (Murietta, CA) received a warning letter on September 19th 2018 based on the outcome of an inspection ending December 18th 2017. The investigators identified 10 deficiencies that render the products adulterated.


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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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