Shanghai Taiheng Industry Co., Ltd. - March 6, 2009
Issue Date
Mar 06, 2009
Region
HQ
Category
Drug
$117.00
Address 1
2715 Long Wu Rd.
Address 2
Building 2 Shanghai Juke Biotech Park
City
Shanghai
Zip/Postal Code
200231
Country
US
Inspection Range
Mar 02, 2009 - Mar 06, 2009
Pages
1
First Observation
The current synthesis process for the crude active pharmaceutical ingredient (API) lacks documented evidence that the critical process parameters are adequately identified, bracketed, and controlled to assure a consistent and reproducible process route that results in pre-defined API quality attributes.
Investigator(s): Charles I. Ahn