US FDA warns Singapore maker of Tiger Balm products
Reuters - Wednesday, August 11
* FDA says products could be blocked unless problems fixed
* Agency warning letter follows October 2009 inspection
WASHINGTON, Aug 10 - Singapore-based Haw Par Corporation Ltd <HPAR.SI>, the maker of Tiger Balm, failed to adequately test its healthcare unit's over-the-counter products, the U.S. drug regulator said in a warning letter made public on Tuesday.
The company's subsidiary, Haw Par Healthcare Ltd, misbranded its Tiger Balm pain-relieving patch, which qualifies as a drug and must be approved, the regulator said.
The warning letter from the U.S. Food and Drug Administration, dated July 20, follows an FDA inspection of the healthcare unit's manufacturing facility in October 2009.
Agency inspectors found that employees were untrained, control procedures were not followed, and laboratory tests had incomplete data, the FDA said.
The company's failure to correct the violations could result in blocking the products, the FDA wrote in the letter, released on the agency's website at http://link.reuters.com/kyr34n.
Representatives for Haw Par could not be immediately reached for comment.
The company's dominant market is Asia, with nearly $42 million in sales of Tiger Balm and Kwan Loong brand products in 2009, according to its annual statement. The company had $10.5 million in sales in its America region.
This is Chinese traditional remedy!
Reuters - Wednesday, August 11
* FDA says products could be blocked unless problems fixed
* Agency warning letter follows October 2009 inspection
WASHINGTON, Aug 10 - Singapore-based Haw Par Corporation Ltd <HPAR.SI>, the maker of Tiger Balm, failed to adequately test its healthcare unit's over-the-counter products, the U.S. drug regulator said in a warning letter made public on Tuesday.
The company's subsidiary, Haw Par Healthcare Ltd, misbranded its Tiger Balm pain-relieving patch, which qualifies as a drug and must be approved, the regulator said.
The warning letter from the U.S. Food and Drug Administration, dated July 20, follows an FDA inspection of the healthcare unit's manufacturing facility in October 2009.
Agency inspectors found that employees were untrained, control procedures were not followed, and laboratory tests had incomplete data, the FDA said.
The company's failure to correct the violations could result in blocking the products, the FDA wrote in the letter, released on the agency's website at http://link.reuters.com/kyr34n.
Representatives for Haw Par could not be immediately reached for comment.
The company's dominant market is Asia, with nearly $42 million in sales of Tiger Balm and Kwan Loong brand products in 2009, according to its annual statement. The company had $10.5 million in sales in its America region.
This is Chinese traditional remedy!
