Wednesday, September 21, 2016

Warning Letter of the Week: simultaneous analysis edition

In a friendly note to Hebei Yuxing Bio-Engineering Co., the FDA notes a problem with their analytical methods: 
2.    Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures.
During the inspection, your firm provided our investigator a chromatogram for an assay analysis of [redacted] batch [redacted] dated August 30, 2014, at 9:46:39 a.m. Your firm later submitted to FDA a different chromatogram corresponding to the same analysis, instrument, date, time, and batch. The second chromatogram appears exactly the same as the one provided during the inspection, but it includes a different method file name, column type and serial number, and system temperature. Both versions of these documents cannot represent the actual assay analysis that you conducted for batch [redacted] on August 30, 2014, at 9:46:39 a.m.
I don't quite understand the circumstances where this could have happened, but perhaps the good folks at Hebei Yuxing have an answer.  

1 comment:

  1. Corrective Actions (do not report to FDA):

    1. Send letters to sympathetic US politicians complaining about job-killing FDA regulations.

    2. Purchase a second chromatographic data system with Sexen Software data manipulation capabilities.

    3. Remove the "It's not a deficiency if the FDA doesn't find out" signs from the lab.


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