Emcure Pharmaceuticals Ltd. - Dec. 28, 2018
Issue Date
Dec 28, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Sanjay Kumar Naik
Contact Title
Associate Director Production
Address 1
Plot No. 12/1 & 2, F-ll Block
Address 2
M.I.D.C., Pimpri
City
Pune
State
Maharashtra
Zip/Postal Code
411018
Country
India
Inspection Range
Dec 27, 2018 - Dec 28, 2018
Pages
3
First Observation
The accuracy, sensitivity, specificity, and reproducibility of analytical methods have not been established and documented to show their appropriateness and fitness for their intended use.
Investigator(s): Kellia N. Hicks and June P. Page