Mw Encap, Ltd. - Dec. 14, 2018
Issue Date
Dec 14, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Jane E. Fraser
Contact Title
Site Head
Address 1
Units 2-8 Oakbank Parkway
City
Livingston, West Lothian
Zip/Postal Code
EH53 OTH
Country
United Kingdom
Inspection Range
Dec 10, 2018 - Dec 14, 2018
Pages
3
First Observation
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.
Electronic records are used, but they do not meet requirements to ensure that they are trustworthy,
reliable and generally equivalent to paper records.
Investigator(s): Mesfin Abdi and Truong Nguyen