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Sub System
System Controls

Analytics Overview

1
Form 483s Issued
0
483s converted to WL
1
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
22 Dec 2023
Eugia US Manufacturing LLC
Drugs
23 Feb 2001
Eli Lilly & Company
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Daniel L Zheng
1
0
James R Birkenstamm
1
0
Ruben C Quintana
1
0
Yoriann M Cabrera Bartolomei
1
0
TITLE/ COMPANY Issue Date Status Details
Input to and output from the computer and records or data are not checked for accuracy
Eugia US Manufacturing LLC
22 Dec 2023 Normal Justification: The observation indicates that controls to manage data within the NetSCADA system are either inadequate or not properly implemented, affecting system reliability.
Excerpt: It is unclear how this data were acquired in this system and whether or not there are controls in place to avoid the addition or deletion of data.
View Details

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