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Sub System
Artwork Management

Artwork Management

View Detailed Analysis

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
02 Jun 2023
BayCare Integrated Service Center, LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Joanne E King
1
0
TITLE/ COMPANY Issue Date Status Details
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
BayCare Integrated Service Center, LLC
02 Jun 2023 Normal Justification: Artwork management processes influence label design and information accuracy. Any failure in this process can result in non-compliant labels being produced.
Excerpt: Specifically, the following information is not found on your drug product labels: a) Dosage form Examples of your drug product labels that do not contain this information:...
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