FDA EIR - Camber Pharmaceuticals, Inc - July 20, 2011

An FDA inspection of Camber Pharmaceuticals Inc., a pharmaceutical distributor located in Piscataway, NJ, took place from July 15-20, 2011. This limited, first-time inspection was conducted in accordance with CP 7356.021, Drug Quality Reporting System NDA Field Alert Reporting, primarily to follow up on a MedWatch report concerning a foreign tablet found in a bottle of Torsemide 100mg, lot E100688. The company is responsible for marketing, sales, and distribution of generic prescription pharmaceuticals manufactured by affiliates. The main issue identified was that Camber Pharmaceuticals lacked its own independent procedures for handling product complaints and recalls. Despite receiving complaints directly from consumers and coordinating recalls, the firm relied solely on the procedures of its parent company, Hetero Drugs Limited (India), with regulatory matters handled by its sister firm, Hetero USA, Inc. Although an FDA Form 483 (Inspectional Observations) was not issued, management was advised to establish their own internal procedures for logging, receiving, communicating, and coordinating complaints and recalls. This action is crucial for ensuring comprehensive operational guidance and adherence to regulatory expectations for a firm directly involved in these critical activities.