FDA Blasts Cispharma in Warning Letter for Poor Injury Investigation
August 5th, 2013 // 12:04 pm @ jmpickett
Latest FDA and cGMP Compliance News
Any time there is an injury at a drug manufacturing plant, it is not a good situation. There is the problem of the injured employee, and then there also is the problem that the firm needs to ensure that there was no product contaminated with blood or human tissue. And according to a recent FDA warning letter, Cispharma really came up short in these areas.
The warning letter was issued to the Cispharma plant in Cranbury, NJ, and it results from an FDA cGMP inspection that occurred in early 2012. FDA stated in the warning letter that the responses to the 483 did nothing to convince them that Cispharma is fixing the problems, so the more serious warning letter was sent. The letter states that there were problems with drug co-mingling, and also there was an accident involving an employee which the firm did not fully investigate, including how the the injury affected operations. In addition to cGMP manufacturing issues, the firm stated that the plant is producing two unapproved drugs in various dosages.
FDA stated that the injury happened during acetaminophen table compression, but Cispharma did a poor job of providing documentation of what actually happened. The company noted that several cleanings of equipment were being done, and that it threw out all product that had been opened when the accident occurred. FDA stated in the warning letter that the company did not explain how it made sure there was no tissue or blood left.
FDA auditors also noted that there was a repeated problem with the firm validating the quality and strength of some products, such as acetaminophen and aspirin. It also was not pleased with complaints that Cispharma got regarding the co-mingling of 100 and 200 mg phenazopyridine tablets. FDA stated that runs for those products are done in sequential fashion, and it stated that Cispharma should have looked closer at this.
Last, FDA stated that Cispharma failed to get approval to product both salsalate and phenazopyridine, and it has to submit NDAs for those drugs.
Validation is a frequent problem for drug companies. On the very same day that Cispharma got its warning letter, FDA gave a warning letter to BTG in the UK for a plant in Oxford CT that is run by its Biocompatibles unit. It stated that FDA had noted issues with process validations, complaint investigations, data analysis and environmental controls. It decided to stop product of various brachytherapy drugs while it dealt with the cGMP violations.
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