Carotech completes FDA GMP inspection

Carotech completes FDA GMP inspection

Carotech’s production facility in Malaysia has been certified current cGMP by the Malaysian Pharmaceutical Control Bureau since 2007.

Carotech Inc., the world’s largest and only GMP-certified natural full spectrum palm tocotrienol producer is pleased to announce that the U.S. FDA has recently completed an inspection of its production facility in Malaysia.

Carotech’s production facility in Malaysia which has been certified current Good Manufacturing Practice (cGMP) by the Malaysian Pharmaceutical Control Bureau (Ministry Of Health of Malaysia) since 2007, was recently inspected by FDA under the Code of Federal Regulations (CFR) Title 21, Part 111 – cGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplement.

“We are very pleased to have our facility inspected by the FDA for GMP compliance. This is another milestone for us in conformance to the cGMP system, as well as quality commitment to our customers. Carotech has always followed stringent cGMP manufacturing guidelines to ensure our products are of the best quality, consistency, and have the purity and safety that meet our customers’ product development requirements, because they too, are subjected to FDA GMP inspection,” says Mr. WH Leong, vice president of Carotech Inc.

“Our customers have confidence in our range of palm phytonutrients. The completion of this FDA inspection further underscores Carotech’s commitment to remain as the leader in supplying GMP certified natural full spectrum palm tocotrienol complex (Tocomin® and Tocomin SupraBio®), natural mixed carotenoids (Caromin®) and phytosterols (Stelessterol™),” adds Mr. Leong.

Carotech has also invested in state of the art analytical instruments for its in house chemical and microbiology laboratory. Its laboratory is ISO/IEC 17025-accredited. In addition, Carotech has obtained Institute Chemistry of Malaysia’s Laboratory Excellence Award for 6 consecutive years since 2007.

Companies (Foreign or U.S.) inspected by the FDA are duly listed on the FDA website under “Inspection Classification Database Search”, accessible through accessdata.fda.gov/scripts/inspsearch.

 

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