Last Updated on March 16, 2025 by The Health Master
USFDA Inspection
Shilpa Medicare has announced that inspection by the United States Food and Drug Administration (USFDA Inspection) has been successfully concluded with zero observations at its subsidiary, Shilpa Pharma Lifesciences Limited, situated in Raichur, Karnataka.
This is the second consecutive time that a USFDA inspection has been concluded at their facility with zero observations, which shows the commitment of the company towards quality drugs as well as regulatory compliance.
Inspection details:
The USFDA inspection at Unit-2 of Shilpa Pharma Lifesciences Limited has been done on March 10 to 14, 2025.
A USFDA inspection with zero observations on Form 483 means that the facility is strictly complying with the quality control measures and following good manufacturing practices (GMP).
A “zero observations” status is a highly appreciable achievement, indicating that the USFDA found no deviations from regulatory standards.
Q. What is meant by “zero observations” during USFDA inspection?
A “zero observation” during USFDA inspection means that there were no deviations with respect to the regulatory standards.
Q. Why is USFDA inspection important for pharmaceutical companies?
USFDA inspections are very important for the pharmaceutical companies, as they point out whether the firm is adhering to GMP and other quality standards laid down by regulatory compliance.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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