> ## 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.

# CGMP Deviations in Henan Lvyuan Inspection
- URL: https://www.fdaweb.com/cgmp-deviations-in-henan-lvyuan-inspection/
- Published: 2026-03-31T12:00:00.000Z
- Updated: 2026-09-14T13:36:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160903

A 9/22-9/26/2025 FDA inspection at the Henan Lvyuan Pharmaceutical Company drug manufacturing facility in Henan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 3/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/henan-lvyuan-pharmaceutical-co-ltd-722497-03262026?ref=fdaweb.com) says the specific violations were:

- failure to properly maintain buildings and facilities used in the manufacture of API; and
- failure to prepare and use master production and control records.

Henan was told to correct the deviations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.