Week of June 24th 2018 | FDA Sent These Warning Letters to Pharma Companies

This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below.

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  • Henan Lihua Pharmaceutical Co. Ltd (China) received a warning letter on June 21st 2018 based on the outcome of an inspection ending December 14th 2017. The firm manufactures APIs and was placed on import alert 66-40 on March 29th 2018. The 2 deficiencies are in the area of data integrity. FDA also included the long version of boilerplate text describing how the firm is to address their data integrity remediation. The deficiencies include but are not limited to:
    • Numerous blank batch records were seen that included a stamp permitting the product to leave the facility (I assume that’s the equivalent of lot release). The FDA states these release forms were:
      • “‘Stamped in advance for convenience of release and warehousing of products’ from your facility. You also said the quality unit record controller ‘did not realize the risk of the damaged lock’ on the cabinet containing the records and stamps.”
    • The firm does not retain all laboratory data. Instruments were configured to permit overwriting of data.

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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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