Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while.
The Trans Ox general manager then acknowledged the analyzer is not used, the warning letter states.Here's the text from the letter itself:
During our inspection of your facility, we documented multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing or from your supplier’s Certificates of Analysis (CoAs).Oops.
According to your batch production records, your results were obtained from a “Post Fill Purity Test.” The records are labeled “ANALYTICAL RESULTS OBTAINED BY USING THE [redacted] OXYGEN ANALYZER.” However, on November 13, 2014, the FDA investigator observed cobwebs between the portable [redacted] Oxygen Analyzer and the adjacent wall. The general manager stated that your firm does not use the [redacted] Oxygen Analyzer, which directly contradicts your batch production records.
Further, on November 13, 2014, our investigator reviewed a number of batch records and asked you why all the analytical results reported on these batch production records were identical. Although your batch production records indicate that analytical results were obtained from the [redacted] Oxygen Analyzer, you responded to the investigator’s question by stating that the values were actually obtained from your supplier’s CoAs. However, the values reported on multiple batch production records disagree with the CoAs for those lots.
a) For instance, the batch production record for your lot 011514 (supplier lot 515244) states your purity test result on the (b)(4) Oxygen Analyzer was 99.9%. In contrast, the CoA for supplier lot 515244, dated December 23, 2013, states 99.74% purity....