Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Data Integrity Violations in USFDA-Approved Pharmaceutical Industries

Data Integrity Violations in USFDA-Approved Pharmaceutical Industries

V. V. Siva Krishna, P.
Puttagunta, Srinivasa Babu

Paperback

Medical Reference

ISBN10: 6206142884
ISBN13: 9786206142881
Publisher: LAP Lambert Academic Publishing
Published: Apr 30 2025
Pages: 96
Weight: 0.31
Height: 0.23 Width: 6.00 Depth: 9.00
Language: English
This book explores the crucial role of data integrity in the pharmaceutical industry, particularly under the regulatory lens of the U.S. FDA. Covering the evolution of data governance principles like ALCOA and ALCOA+, it analyzes real-world case studies including major violations by industry leaders like Ranbaxy. The book examines FDA warning letters, 483 observations, and the statistical rise in data integrity breaches globally, especially in India and China. It highlights the consequences of violations - from product recalls to import bans - and presents actionable remediation strategies for maintaining compliance. Designed for professionals and scholars, this work serves as a vital guide to understanding how trustworthy data underpins public health, regulatory success, and corporate reputation.

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