Week of December 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.


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  • DRUG:  CAO Medical Equipment Co., Ltd. (Hebei, CHINA) received a warning letter on November 30, based on the outcome of an inspection ending July 20, 206. The firm was placed on Import Alert 66-40 on November 26, 2018.  FDA recommends the firm employ qualified consultants to assist them in coming into GMP compliance. And finally, the firm recalled all drug products in the US market within expiry on November 9, 2018.  Deficiencies include but are not limited to:
    • The firm failed to test finished drug products for aerobic microbial count and objectionable microorganisms prior to release.
    • The firm did not test incoming APIs and other components used in manufacture, but rather relied on the suppliers COA without verifying the results.  This is most important because the firm uses glycerin as an ingredient. There is concern that diethylene glycol or ethylene glycol may be present.
    • The firm’s equipment lacked IQ/OQ and PQ.  Further, the facility is open to the outside so there is concern about the presence of “vermin, animal waste, and various contaminants.”
    • Manufacturing processes are not validated nor does the firm have an ongoing program for monitoring in process controls.

  • HUMAN CELLS AND TISSUES:  Genetech (San Diego, CA) received a warning letter on November 29, 2018 based on the outcome of an inspection of their facility ending June 22, 2018.  This site processes human umbilical cord blood derived cellular products for allogenic use. Here is the FDA’s statement on enforcement discretion in this area. This is an unusually scathing warning letter with 19 identified deficiencies including but not limited to:
    • Failure to monitor and control donor eligibility.  Neither Genetech, Liveyon (their distributor) or their suppliers determine donor eligibility. A huge gap. The first four deficiencies address failure to screen donors or test donor specimens.
    • Products distributed since mid-2017 did not include a statement of donor eligibility or a summary of records used to make donor eligibility decisions.
    • Aseptic processing operations are not supported by medial sill simulations to qualify the state of control; rooms are not classified with respect to air quality; there are no gowning procedures.
    • Cleaning processes are not validated nor are cleaning agents justified or rotated.  Cleaning records do not include dilutions or contact time. Cleaning is not performed between the manufacture of batches.
    • The manufacturing process has not been validated, nor have changes to the process been validated.
    • Samples with failed sterility tests were not investigated to identify the contaminating organisms.
    • Unlabeled vials of product from different donors are not adequately secured in a way to ensure they are not mixed up.
    • There are no written procedures describing receipt and approval or rejection of incoming umbilical cord blood.  There are no tests or examination of several raw materials/components before release for use.
    • Not all processing steps were documented in a batch record.  
    • A one-year expiry is assigned with no data to support this time period.
    • The firm does not maintain distribution records.
    • The firm has not had a Quality Unit since the time they began operations in mid-2017.


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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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