Fenwal International, Inc. – FDA Warning Letter, Sep 26, 2019

The FDA issued a Warning Letter to Fenwal International, Inc. following an inspection from September 16-26, 2019, at their Maricao, PR facility. The inspection revealed significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of blood-pack units (BPUs) and InterSol (Platelet Additive Solution).

Key violations include inaccurate and incomplete documentation of microbiology laboratory test results. FDA investigators observed discrepancies between recorded microbial plate results and actual microbial growth, including underreporting of CFUs and failure to document total counts. Additionally, changes to bioburden data results were made improperly, violating SOP MA-03-01-013. These data integrity breaches raise concerns about the validity of all quality control laboratory results.

The FDA reviewed Fenwal's responses dated October 18, 2019, December 20, 2019, February 20, 2020, and April 24, 2020, but found them inadequate. Concerns remain regarding the extent of underreporting, the lack of a market action plan for batches failing sterility criteria, and an update on investigation 593423. Furthermore, over 350 open complaints, some dating back to July 2018, regarding issues like "leak before use," "particulate matter," "discolored solution," and "mold," require a completion