09.08.11
Sabinsa Corporation, East Windsor, NJ, has received confirmation that five of its SAMI Labs in India (the company’s manufacturing center) recently underwent FDA inspection. FDA found no issues of concern in four of the facilities inspected. The FDA had one 483 observation in the herbal intermediates manufacturing facility. Sabinsa corrected the minor issue and sent the compliance report to FDA within days of the inspection, the company said. The issue involved a polyliner becoming tangled in the conveyer belts leading to the extraction chamber; corrective action included changing to HDPE bags without lining and improving the hopper and mesh at the point of feeding raw material into the extraction equipment. The inspected factories are located in Kunigal, Nelamangala, Dobaspet (all in the state of Karnataka), and in Genome Valley in Hyderabad.
