Abbott Healthcare, Ltd. - Oct. 29, 2015
Issue Date
Oct 29, 2015
Region
Southeast
Category
Drug
$117.00
Contact Name
Otto E. Aldahondo
Contact Title
Site Director
Address 1
Road #2 KM 58.2
City
Barceloneta
State
PR
Zip/Postal Code
00617
Country
United States
Inspection Range
Oct 20, 2015 - Oct 29, 2015
Pages
4
First Observation
Investigation and documentation activities of exception (nonconformance) reports completed on site as described in approved procedures ... CAPA and Exception Report Process, do not always ensure timely and complete documentation of activities executed to support conclusions or implemented corrective/preventive actions identified on respective exception reports.
Investigator(s): Noreen Muniz