> ## 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.

# 3 Observations from Lupin Pithampur Inspection
- URL: https://www.fdaweb.com/3-observations-from-lupin-pithampur-inspection/
- Published: 2025-10-16T12:00:00.000Z
- Updated: 2026-09-14T15:24:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160054

FDA has released the form FDA-483 issued following a 7/7-7/17 inspection at the Lupin drug manufacturing facility in Pithampur, Madhya Pradesh, India. The three inspection observations were:

- failure to test each component for conformity with all appropriate written specifications for purity, strength, and quality;
- failure to thoroughly review any unexplained discrepancy, whether or not the lot has already been distributed; and
- failure to establish written procedures describing the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch.