WARNING LETTER Fenwal International, Inc. JUNE 14, 2020
RECORDS AND REPORTS
On September 16, 2019, your Microbiology Laboratory did not accurately document test results. Please be advised that incomplete and inaccurate records call into question the integrity of all your microbiological data. The deficiencies include, but are not limited to the following:
1. FDA investigators observed several data discrepancies between recorded microbial plate results and actual observed microbial growth which were verified with the Microbiology Laboratory Manager. Inaccuracies like these create the potential for missing the timely detection of microbiological contamination. For example:
a. Your Microbiology Laboratory Analyst reported (b)(4). The media plate was (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4). FDA investigators found multiple other similar examples of underreporting.
b. Your Microbiology Laboratory Analyst failed to document the CFU Total Count value for (b)(4). The media plate was subsequently (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4).
b. Your Microbiology Laboratory Analyst failed to document the CFU Total Count value for (b)(4). The media plate was subsequently (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4).
2. Per SOP MA-03-01-013, entitled "Buenas Practicas De Documentacion", changes to original (b)(4). However, bioburden data results for batch FM19I10017 were (b)(4) by your Microbiology Laboratory Analyst (b)(4)...
