An injury in a manufacturing plant is a bad situation. First, there is an injured employee, and second, the drugmaker needs to make sure there is no product contaminated with blood and tissue. And that is one area among several in which Cispharma came up short, according to a warning letter issued by the FDA.
The warning letter is for Cispharma's plant in Cranbury, NJ, and covers an inspection that occurred in March and April of 2012. The FDA says the responses it has been getting to its Form 483 have not convinced it that the drugmaker is on top of problems, so it issued the warning letter as well. The document takes the company to task for problems ranging from potential co-mingling of drugs to the incident in which it said the drugmaker failed to thoroughly investigate the impact of an injury to an employee. In addition to manufacturing problems, the FDA said the plant is making two unapproved drugs in different dosages.
The FDA said the injury occurred during compression of acetaminophen tablets, and that Cispharma didn't do a good job of documenting what specifically happened. While the drugmaker said "several extensive cleanings were performed" and that it discarded all of the product that was opened when the accident happened, the FDA said it didn't say how it "ensured there was no blood or tissue remaining."
Inspectors also said there was a repeat problem with Cispharma validating the strength and quality of some of its products, including salsalate, acetaminophen and aspirin. It also was not satisfied that a complaint the company received about 100 mg and 200 mg phenazopyridine HCI tablets being comingled. The company said it probably happened at the pharmacy. But the FDA noted the runs for the products occurred sequentially, raising the possibility it occurred at the plant, and said Cispharma should have checked that out.
Finally, the FDA said Cispharma is not approved to make the salsalate and phenazopyridine and needs to get applications submitted for the drugs in the dosages it is manufacturing.
Validation problems often trip up drug manufacturers. On the same day the Cispharma warning letter was posted to the FDA website, the U.K.'s BTG said that it has received an FDA warning letter for a plant in Oxford, CT, operated by its Biocompatibles unit. It said the FDA noted problems with its process validations, as well as data analysis, complaint investigations and environmental controls at the facility. It has voluntarily halted production of brachytherapy products while it addresses the problems.
- read the warning letter