Jerome Stevens reviews reviews
During an inspection of Jerome Stevens Pharmaceuticals' drug manufacturing facility in Bohemia, New York, conducted between August 27 and September 12, 2007, inspectors found both CGMP deviations and deviations from adverse event reporting regulations and other post-marketing reporting regulations. The company provided a written response, but the regulator deemed the company's explanations inadequate and noted that some of the deviations are recurrences of violations discovered during a 2005 inspection.
The FDA's overriding concern in warning letter NYK 2009-03 issued in October 2008 was Jerome Stevens' inadequate annual reviews. Product reviews from 2006, the letter says, "failed to address such issues as trends in complaints, investigations, rejected or reprocessed batches, and other manufacturing issues that warrant corrective action."
Another concern was the company's failure to conduct and document a thorough investigation of any unexplained discrepancy or failure of a drug product batch to meet its specification, according to the letter. Although the company reported in its response that a drug's batch blend weight was greater than normal, inspectors found no record of any discrepancy.
The company also said that an investigation was conducted immediately after completion of the blend procedure, but no record of an investigation was available during the inspection or in the response letter. The only records of an investigation provided were annotations to the batch record stating that an additional amount of a particular substance was added to the batch by mistake.
"This does not suffice as a record of investigation," the FDA's letter says. It also notes that the company's failure to conduct adequate investigations was documented in inspections conducted in 2002 and 2006.