The FDA issued a Form 483 to AbbVie for its handling of complaints and samples.
In a November/December 2017 inspection of the company’s North Chicago facility, the FDA found the facility’s standard operating procedures did not require it to procure complaint samples or test retain samples in the event of fatalities.
Investigators found several complaints for which there was no documentation of an evaluation to determine if there were similar complaints for different strengths of the synthetic hormone Lupron (leuprolide acetate).
The agency also found no documentation of combined evaluations by the manufacturer of the syringes and the packager to assess a potential root cause for leaking and fatalities.
The facility also failed to visually examine reserve samples for evidence of deterioration or batches of drug products selected by acceptable statistical procedures at least annually.
AbbVie also failed to extend its investigations of batches that did not meet specifications to other batches of the same product or other products that might have been associated with the specific failure or discrepancy.
In addition, the company did not follow its written production and process control procedures, the agency said.