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AbbVie Cited Over Complaint Handling, Product Sampling
Drugs Inspections and Audits
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).