Macfarlan Smith Ltd. - Nov. 10, 2017
Issue Date
Nov 10, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Steven Thompson
Contact Title
Site Director
Address 1
10 Wheatfield Rd.
City
Edinburgh
Zip/Postal Code
EH11 2QA
Country
United Kingdom
Inspection Range
Nov 06, 2017 - Nov 10, 2017
Pages
2
First Observation
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMPs.
Investigator(s): Nicole E. Knowlton and Rozelle G. Smith