Week of January 6th 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere that focused on aseptic processing and data integrity.


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  • Akorn, Inc. (Decatur, IL) received a warning letter on January 4, 2019 based on the outcome of an inspection at their site ending May 16, 2018.   The deficiencies are in the area of aseptic processing and data integrity. FDA advises the firm to employ qualified consultants to help them come into GMP compliance and suggests they employ ICH Q8(R2), Q9 or Q10 to improve their quality system. FDA also asked them to address their ‘short’ version of data integrity remediation. Deficiencies include but are not limited to:
    • Poor aseptic behavior including failure to log interventions in the batch records; use of gloves from non-integral packaging where foreign particles were evident; inadequate cleanroom design.
    • Personnel monitoring is inadequate because staff sanitized their hands prior to sampling, and failure to trigger an investigation when staff in the ISO 5 cabinet has one CFU/glove on a repeated basis.
    • Cleaning program is inadequate because steps were skipped, not performed properly and some equipment was not sanitized.
    • The firm did not perform impurity testing during stability on two products since 2016.  At the time of the inspection, the firm did not have a validated method.


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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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