Wednesday, June 18, 2014

Warning Letter of the Week: foreign objects not appreciated

From our friends in Silver Spring, a fun letter to Tianjin Zhongan Pharmaceutical Co:
During our inspection, the investigator observed that the [redacted] manufacturing workshop [redacted], used for [redacted] steps, contained significant particulate material, [redacted] fluid, and a plastic tube (apparently from a pen) in the bottom of the various [redacted]. These [redacted] were labeled as clean.  
The samples collected of the residues were insufficient to allow for an adequate investigation. You did not initiate an investigation prior to the investigator’s observation. Your investigation consisted of a high performance liquid chromatography (HPLC) assay test for [redacted], the last API manufactured in that [redacted], even though the sample was a complex mixture of [redacted] phases. You conducted no further testing, and disposed of the sample after the HPLC analysis.
 It's funny what gets into equipment sometimes. Oops. 

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