Lotus Pharmaceutical Co. Ltd. - June 4, 2015
Issue Date
Jun 04, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Mike Stradling
Contact Title
Factory Vice President
Address 1
30 Chenggong 1st Rd.
City
Sinsing Village, Nantou
Zip/Postal Code
54066
Country
Taiwan
Inspection Range
Jun 01, 2015 - Jun 04, 2015
Pages
2
First Observation
Your firm Quality Unit failed to fully follow the responsibilities of assuring that processes and procedures, among others, are approved in accordance to established specifications and using sound scientific rationales.
Investigator(s): Heriberto Negron-Rivera