FDA inspects five Sabinsa/SAMI Labs facilities in India

FDA inspects five Sabinsa/SAMI Labs facilities in India

Five of SAMI Labs facilities in India recently underwent inspection by the US Food & Drug Administration. Sami Labs is registered with the FDA for dietary ingredient manufacturing and therefore subject to audit by FDA at any time.

 

Five of SAMI Labs (Sabinsa's manufacturing center) facilities in India recently underwent inspection by the US Food & Drug Administration. Sami Labs, the manufacturing arm of Sabinsa Corporation, is registered with the FDA for dietary ingredient manufacturing and therefore subject to audit by FDA at any time.

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 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.

“While we would prefer, of course, a perfect inspection report, we remain proud of the quality of our manufacturing facilities,” said Sabinsa Marketing Director Shaheen Majeed. “We have a dedicated staff that takes great pride in the quality of our facilities.”

The inspected factories are located in Kunigal, Nelamangala, Dobaspet (all in the state of Karnataka), and in Genome Valley in Hyderabad.

Dr. Majeed founded the Sabinsa Corporation, a research-oriented pharmaceutical and nutraceutical marketing company in 1988. In 1991, Dr. Majeed set up a research group at Bangalore, India, Sami Labs Limited. Today, Sami is a Research, Development and Manufacturing group in the areas of Standardized Herbal Extracts, Cosmeceuticals, Probiotics, Spice Extracts, Minerals, Fine Chemicals, Phytochemicals and Specialized drug intermediates used in the nutritional, pharmaceutical and food industries. The combined companies have nearly 800 employees.

Sabinsa's mission is to provide alternative and complementary natural products for human nutrition and well-being. Over the past 20 years, Sabinsa has brought to market more than 100 standardized botanical extracts and privately funded several clinical studies in conjunction with prestigious institutions in support of these products. With more than 100 full time scientists conducting ongoing research in India and the United States, Sabinsa continues to develop and patent phytonutrients for the world market. All products intended for human consumption are certified Kosher and Halal. For more information, visit www.sabinsa.com & www.sabinsacosmetics.com.

 

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