...b. In April 2014, your firm received a customer complaint concerning Bacillus spp. contamination of [redacted], API lot [redacted]. Your tests of the returned customer samples confirmed microbial contamination, including both high levels of bioburden and Bacillus spp. contamination. During your investigation, your firm did not extend the investigation to any other batches potentially affected. In addition, deficient sampling procedures compromised your firm’s ability to detect the contamination your customer found. Your firm sampled [redacted] per batch and had no statistical justification that this sample was representative of the entire batch.Oh, dear.
While your response focuses on detecting future contaminations prior to release, it fails to adequately identify the potential root causes of the contamination. Your response states that you have updated your Final Product Adjustment SOP and Product Homogenization SOP to add a step: [redacted], API. However, you have no data to support this will adequately remediate the contamination issues....
Wednesday, June 3, 2015
Warning Letter of the Week: bacterial growth edition
From the good folks at Center for Drug Evaluation and Research, a love note to some folks in the Czech Republic: