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Sub System
Tech Transfer

Analytics Overview

2
Form 483s Issued
0
483s converted to WL
2
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
20 Sep 2024
Aarti Drugs Limited
Drugs
21 Jun 2024
Cipla Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Eileen A Liu
1
0
Joseph A Piechocki
1
0
Rajiv R Srivastava
1
0
Suzanne N Vallez
1
0
Tamil Arasu
1
0
TITLE/ COMPANY Issue Date Status Details
Test procedures is not scientifically sound and appropriate to ensure that raw materials, intermediates, and APIs, conform to established standards
Aarti Drugs Limited
20 Sep 2024 Normal Justification: The observation cites discrepancies in method verification, highlighting involvement of tech transfer issues.
Excerpt: Your method verification/transfer Report confirmed use of two different batches contrary to SOP.
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Cipla Limited
21 Jun 2024 Normal Justification: Proper transfer of methods ensures continuity and consistency in testing across different sites.
Excerpt: Test methods for numerous approved products were not appropriately validated/verified/transferred.
View Details

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