The problems were flagged up during an inspection last July after testing of a recalled batch of the anesthetic propofol that had been made at the facility revealed it was contaminated.
At the time the agency said Teva had been “unable to determine the cause of an out-of-trend level of bacterial endotoxin contamination found in three vials,” and that “no corrective action was taken in response to this finding.”
The Food and Drug Administration (FDA) subsequently ordered Teva to develop revised testing protocols, which the Israeli firm duly created and filed with the agency last autumn.
However, a warning letter published on the FDA website yesterday, indicates that Teva’s response was insufficient on a number of grounds.
For example, the agency said that the revised bulk emulsion and finished product testing plan proposed by Teva “does not include a scientific rationale” for the proposed sample size.
The agency is also critical of revisions to standard operating procedures that require “enhanced visual examination” of finished vials found to contain water as the exited the depyrogenation stage of the production process.
It said that proposed changes do not “describe specific procedure for ensuring investigations are extended to other batches of the same drug product, or other potentially affected drug products, when unexplained discrepancies occur.”
Teva said it will respond to each of the FDAs comments and added that it has rescheduled the annual shutdown of the Irving facility from December to this week to address the problems.