Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated June 13, 2025, following a comprehensive inspection by the United States Food and Drug Administration (USFDA). The inspection revealed eight major observations related to deficiencies in aseptic practices, process validation, equipment maintenance, data integrity, and […]
Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart from the third-party services like calibration and annual maintenance also impacted due to […]
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can also go to the FDA ORA FOIA electronic reading room and can find […]
