Last Updated on May 9, 2025 by The Health Master
USFDA inspection
Zydus Lifesciences recently underwent a United States Food and Drug Administration inspection (USFDA Inspection) at its Active Pharmaceutical Ingredient (API) manufacturing facility situated in Dabhasa, Gujarat.
This USFDA inspection was conducted with effect from April 21st to April 25th, 2025, is a standard procedure to check whether the facility is adhering to regulations required for manufacturing standards in the pharmaceutical industry.
Six Observations Issued
Following the completion of the USFDA inspection, a total of six observations were issued to Zydus Lifesciences.
While the details of these observations were not mentioned in the company’s official statement.
Zydus Lifesciences provided important information by stating that none of the observations raised by the USFDA were related to data integrity.
This is a very important point, as data integrity issues can have serious problems for the reliability and safety of drugs.
Zydus is in the process of Resolution of the issues
Zydus Lifesciences conveyed a clear message of its ability to address the observations raised during the USFDA inspection in a quick manner.
This proactive approach shows that the company is already taking necessary steps to rectify the observations pointed out during the USFDA inspection.
Q. What is an API ?
A. An Active Pharmaceutical Ingredient (API) is an active component of a drug responsible for the therapeutic effect of the drug.
Q. What is a USFDA inspection?
A. A USFDA inspection is a routine check done by the US Food and Drug Administration to monitor pharmaceutical manufacturing units and ensure that the company complies with quality standards and regulations.
Q. What is Form 484 issued by the USFDA?
A. Form 483 is issued by the USFDA with details of the observations detected during the inspection at the drug manufacturing facility.
Q. Why is data integrity important in a pharmaceutical manufacturing unit?
A. Data integrity is an important issue because it ensures the accuracy and reliability of all data and records related to the manufacturing, testing, and quality control of drugs.
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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