Last Updated on October 9, 2024 by The Health Master
USFDA inspection
Leading Indian pharmaceutical manufacturer Divi’s Laboratories Limited (DVI) has successfully concluded a recent US Food and Drug Administration inspection (USFDA inspection) of its Unit II manufacturing facility located in Chippada Village, Visakhapatnam, Andhra Pradesh.
The inspection, which ran from July 11th to July 19th, 2024, resulted in just one procedural observation, highlighting the company’s commitment to Current Good Manufacturing Practice (cGMP) compliance.
USFDA Inspection Details
The USFDA conducts cGMP inspections to ensure that pharmaceutical manufacturing facilities adhere to internationally recognized quality standards.
These inspections evaluate various aspects of a facility’s operations, including:
- Production and process controls
- Data integrity
- Equipment maintenance
- Facility and personnel qualifications
Divi’s Laboratories reports that the USFDA identified a single procedural observation during the inspection.
While the company did not disclose the specific nature of the observation, they have assured investors in a BSE filing that it will be addressed within the stipulated timeframe.
Significance of the USFDA Inspection
A successful USFDA inspection is a significant achievement for any pharmaceutical company aiming to export drugs to the lucrative US market.
It signifies that the inspected facility meets the USFDA’s rigorous quality standards and ensures the safety, purity, and efficacy of manufactured medications.
For Divi’s Laboratories, this successful inspection reinforces their position as a trusted supplier of Active Pharmaceutical Ingredients (APIs) and intermediates to global pharmaceutical companies.
Looking Ahead
Divi’s Laboratories’ commitment to cGMP compliance and successful completion of the USFDA inspection are positive indicators for the company’s future growth.
Investors can be confident that Divi’s products are manufactured to the highest quality standards, ensuring patient safety and regulatory compliance worldwide.
Key Takeaways:
- Divi’s Laboratories Unit II underwent a USFDA cGMP inspection from July 11th to July 19th, 2024.
- The inspection resulted in one procedural observation, which Divi’s will address within the stipulated timeframe.
- A successful USFDA inspection strengthens Divi’s position as a reliable supplier of high-quality pharmaceutical ingredients.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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