Panacea Biotec, Ltd. - Dec. 13, 2017
Issue Date
Dec 13, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Rajeeva Kumar Mangalum
Contact Title
Site Head
Address 1
Malpur
Address 2
Baddi, Solan
City
Himachal Pradesh
Zip/Postal Code
173205
Country
India
Inspection Range
Dec 04, 2017 - Dec 13, 2017
Pages
10
First Observation
Currently executed procedures for the environmental monitoring of the ... aseptic filling room and ... filling-line system ... do not include enough samples to assure a more accurate and/or thorough assessment on the microbiological quality and/or condition of the aseptic-filling areas and equipment monitored using these procedures.
Investigator(s): Jose A. Cruz-Gonzalez