Teva Called Out for Complaint Handling, Written Procedures

The FDA hit Teva with a Form 483 for its handling of complaints and other deficiencies at its facility in Jerusalem, Israel.

The agency cited the generic drug giant for not consistently following up on complaints about the lack of effect of drugs with testing for quality.

The company was also late in evaluating potential complaint trends, although its standard operating procedure was put in place to allow early detection and evaluation of impacts on product safety and efficacy.

In addition, the agency cited Teva for allowing employees to shred documents, printouts, labels and other items while they worked on compression and encapsulation activities.