In Our World-Class Facilities
GBI occupies a facility of over 28,000 sq. ft. that is utilized for GMP manufacturing and process development, QA and QC labs and support services. Manufacturing equipment and its parameters are monitored 24-hour via a computer controlled alarm system. GBI is equipped with emergency backup generators in the event of a power loss. GBI has a facility staff on site to aid in monitoring and maintenance of manufacturing equipment and its associated utilities.
We Welcome Audits
We're proud of our facility and our staff. Stop by and see for yourself. We've had over 85 successful audits from clients, auditors and regulatory agencies. Most recently, we were audited by the FDA.
"Regarding the FDA audit, no observations were listed on an FDA-483 form, noted Bansi Bhan, CFO / Interim CEO. "The FDA personnel observed and reported that our personnel are proactive in making sure that the proper procedures are in place, noting that '...the firm presented evidence that they were dynamically working toward the building of a robust, quality system.'"
"It may seem unusual, but we welcome audits, a fresh perspective on our system and processes is invaluable" commented Rajiv Modha, Director of QA/QC. "At GBI, both Operations and Quality groups work synergistically, taking a holistic, risk-based approach to quality and compliance, building quality in our processes," continued SooYoung Lee, Senior Vice President, Operations.
"It is refreshing that the people who audit us tend to be very complimentary about the skill level and commitment of our staff, and the sophistication of our facility on an FDA-483 form." noted Bansi.
See what the FDA had to say.
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