GVK says Ahmedabad bioscience's unit successfully clears US FDA audit
30 Jul 2012
Asia's leading contract research organisation, GVK Biosciences, today said that its Ahmedabad clinical pharmacology unit had successfully cleared the US FDA Audit with zero 483s / observations from the agency.
The US FDA's form FDA 483 is used by the FDA that lists observations made by the FDA representatives during the inspection of the facility and document all shortcomings and deficiencies discovered in the units under audit during these inspections.
The US FDA inspectors visited and audited a 'first-to-file' study for one of GVK Biosciences's customers.
"The GVK Biosciences Ahmedabad facility, commissioned in 2010, has three clinics with 110 beds. The facility has been inspected and approved by the Drugs Controller General of India, ANVISA-Brazil and the ministry of health of Turkey," the company said in a statement.
The Ahmedabad facility carries out bioavailability and bioequivalence (BA / BE) studies that are submitted to various regulatory agencies including FDA, TGA (Australia), European regulatory agencies, Health Canada, ANVISA-Brazil and MoH Turkey.
Manni Kantipudi, chief executive officer, GVK Biosciences, said, "This is a clear testimony of the high standards of quality and processes followed at GVK BIO. The sponsor can now carry out BA/BE studies at either of our sites, Ahmedabad or Hyderabad, with a wider choice of population and capacities".
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