US FDA captured 3 minor observations under Form 483 for Neuland Labs in Unit 3. Unit 3 had only gone through Desktop inspection by the US FDA till now but it seems this is an in-person inspection done for the first time. Unit 3 is where most CapEx is being focused towards from FY’24 and beyond.
I saw the past Observation 483 being raised for other facilities of Neuland Labs and the manner in which they were handled. Nothing concerning came through. The markets too reacted decently in the past by not showing a severe decline/dip.
I tried checking the US FDA website if any details have come through regarding this particular observation but I could not find any.
Does anyone have any intel on this?
Disc: Invested for the long term, my thesis for Neuland is ethics and clean management
Neuland_Labs_Observation_483.pdf (267.8 KB)
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