Successful Inspection by the FDA of Intertek Pharmaceutical Services in San Diego
San Diego, CA - Intertek Pharmaceuticals Services announced today that its San Diego, CA Bioanalytical Immunochemistry facility successfully complete a seven-day inspection by the United States Food and Drug Administration (FDA).
On September 20th, an investigator from the FDA visited Intertek’s San Diego facility for a routine inspection to assess the Intertek’s facility for overall compliance with Good Laboratory Practice (GLP) regulations. During the course of the audit, the investigator toured Intertek’s facility over several days, focusing on sample management, equipment and equipment records, archival practices (storage, retrieval and tracking of archived data), and QA reporting functions. The FDA investigator also reviewed multiple reports, including several method validations and sample analysis projects.
Upon completion of the inspection, the investigator reported no findings and Form 483 was not issued.
“Intertek Pharmaceutical Services operates under the most stringent of Quality systems assuring our clients that the quality of data received will always be of the highest standard”, stated Dominique Gouty PhD., Director of Intertek Pharmaceutical Services in San Diego ”All laboratory personnel that were interviewed gave professional confident responses related to their jobs and responsibilities”.
“We are extremely pleased with this successful inspection, which confirms Intertek’s commitment to meeting the highest quality standards. It was incredibly gratifying to see the San Diego facility complete such an intense audit with no findings.” states Dr. Andrew Swift, Executive Vice President of global operations for Intertek Chemicals & Pharmaceuticals.
For more information about Intertek Pharmaceutical Services visit: http://www.intertek.com/pharmaceutical/
Intertek is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers’ products and processes, supporting their success in the global marketplace. With a network of more than 1,000 laboratories and offices and over 33,000 people in more than 100 countries, Intertek helps its clients to meet end users’ expectations across increasingly diverse quality, health, environmental, safety and social accountability aspects in virtually any market around the world. Visit www.intertek.com
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