The inspection, which covered the facility’s injectable and ophthalmic manufacturing operations, was conducted from August 13 to August 21, 2026, Caplin Point said in a regulatory filing on Friday.
At the end of the inspection, the US drug regulator issued a Form 483 containing 10 observations.
Caplin Point said all the observations were procedural in nature and none related to data integrity. It added that none of the observations were repeats of those raised during previous inspections.
The company said it is addressing the observations and will submit its response to the USFDA within the stipulated timeframe.
A Form 483 is issued by USFDA inspectors at the end of an inspection when they observe conditions that, in their judgment, may constitute violations of US food and drug regulations.
Shares of Caplin Point Laboratories closed 1.58% higher at ₹2,569.70 on the NSE on Friday, August 21.
