Divi’s Laboratories has reported a positive regulatory development, confirming that the US Food and Drug Administration (USFDA) has successfully completed a comprehensive cGMP inspection at the company’s Unit-I facility located in Lingojigudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri district in Telangana. The inspection was conducted over five days, from November 10 to November 14, 2025.
What makes this update significant is that the audit concluded with zero Form 483 observations. In regulatory terms, this indicates that the USFDA inspectors did not find any deviations from current Good Manufacturing Practices (cGMP). For a pharmaceutical manufacturer, such an outcome strongly reinforces the company’s quality systems, compliance culture, and operational standards.
A clean USFDA inspection is especially important for companies like Divi’s Laboratories, which supply active pharmaceutical ingredients (APIs) and intermediates to global markets. With no 483s issued, the company not only strengthens its regulatory track record but also boosts confidence among international partners, customers and investors.
This development is expected to be seen as a positive sign for future approvals, export momentum and overall business stability.
