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Cambridge Major Announces Positive Results of Recent FDA Inspections
Three Pre-Approval and One General Inspection; No Form 483’s issued
May 21, 2007 Germantown, WI USA: Cambridge Major Laboratories today announced a successful FDA inspection, conducted on April 27th, April 30th, and May 1st through May 4th. Both of the Company’s GMP manufacturing facilities were the subject of the inspection which included three pre-approval inspections and a general quality systems inspection of both sites. No form 483 observations were issued.
The inspection represents the second for Cambridge Major’s newest facility and the fifth inspection over the past five years. As the company continues to commercialize API’s, the number of pre-approval inspections has been consistently growing. Currently, Cambridge Major manufactures several commercial products including innovative new drugs, generic substances, and medical imaging agents.
“The inspection was very thorough including physical observation of processes and procedures in plants and labs,” said Dr. Michael Major, President and CEO of Cambridge Major Labs. “Our objective is always to ensure that our systems are in compliance with FDA requirements. I am very happy with the outcome of the inspection which corroborates the full devotion of the management and employees. Keeping the facility clean and organized, and all systems in compliance has definitely paid off.”
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