> ## 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 Daewoong Pharma with 10-item Form 483
- URL: https://www.fdaweb.com/fda-hits-daewoong-pharma-with-10-item-form-483/
- Published: 2018-01-22T12:00:00.000Z
- Updated: 2026-09-14T23:15:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140566

FDA has issued South Korea-based Daewoong Pharmaceutical a 10-item [Form 483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM593139.pdf?ref=fdaweb.com) after an 11/2017 inspection found significant GMP violations at the drug substance and sterile drug manufacturer. For example, the firm was cited for failing to review any unexplained discrepancy and the failure of any batch to meet its specifications. The agency also cited it for not having scientifically sound sampling plans, specifications and test procedures. And it was cited for not adequately monitoring the environmental conditions in aseptic processing areas.