FDA EIR - Camber Pharmaceuticals, Inc - November 25, 2019

An FDA Establishment Inspection was conducted at Camber Pharmaceuticals, Inc. in Piscataway, NJ, on November 25, 2019. The inspection focused on the company's operations as a warehouse and distributor of prescription and over-the-counter drug products, ensuring compliance with current Good Manufacturing Practices (cGMP) as outlined in CP7356.002, Drug Manufacturing Inspections. During the comprehensive walkthrough of the warehouse and review of distribution processes, no deficiencies or violations were observed. Consequently, no FDA-483 (Inspectional Observations) was issued to Camber Pharmaceuticals, Inc., indicating a satisfactory inspection outcome. The facility maintains controlled conditions for humidity and temperature and utilizes a system for efficient product routing from receiving to distribution. The company primarily handles pre-packaged products from its parent company, Hetero, and its affiliates, without engaging in manufacturing, opening, or repackaging activities at this location. While no regulatory issues were identified, a discussion occurred regarding the firm's drug registration status, given its role solely as a warehouse and distributor. Camber's President indicated plans to consult with the parent company on this matter and also mentioned an upcoming relocation to a larger facility. This inspection reinforced the company's status of compliance, mirroring the 'No Action Indicated' classification from its previous FDA inspection in 2011.