> ## 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.

# FDA Hits India Drug Maker with Form 483
- URL: https://www.fdaweb.com/fda-hits-india-drug-maker-with-form-483/
- Published: 2018-05-21T12:00:00.000Z
- Updated: 2026-09-15T00:06:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141489

FDA has released a three-page [Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM607957.pdf?ref=fdaweb.com) sent to Auronext Pharma following a March inspection of the firm’s Bhjwadi, India manufacturing facility. Agency investigators said the firm has unsubstantiated ranges for a critical process parameter for its vial sealing machine. FDA also said employees lacked the training to perform their assigned functions. Additionally, the established laboratory control mechanisms are not drafted by an appropriate organizational unit.