> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ‘Procedural Deficiency’ in Lupin Tarapur Inspection
- URL: https://www.fdaweb.com/procedural-deficiency-in-lupin-tarapur-inspection/
- Published: 2018-09-11T12:00:00.000Z
- Updated: 2026-09-15T00:31:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142320

An FDA 8/27-8/31 inspection at the Lupin Tarapur, India, drug manufacturing facility closed with one inspection observation that the company termed a “procedural deficiency” in a [statement](https://www.bseindia.com/xml-data/corpfiling/AttachHis/6d8ba47b-6f63-4f32-91fd-7bd26c7d18c6.pdf?ref=fdaweb.com) to news media in India. The statement says the inspection focused on cGMP compliance and also on the safety of Lupin’s valsartan, losartan, and irbesartan active pharmaceutical ingredients (API) in light of a regulatory alert on the NDMA impurity in valsartan API supplied by some companies. “During the inspection, FDA concluded that the manufacturing processes of Lupin ‘sartans’ are safe with no chance of presence of the NDMA impurity in the APIs,” the statement says.

An 11/2017 FDA Warning Letter [cited](https://www.fdaweb.com/cgmp-violations-found-in-2-lupin-facilities/) cGMP issues at Lupin’s Goa and Indore manufacturing facilities.