FDA Inspection 1228837 — Shandong Xinhua Pharmaceutical Co., Ltd. FDF Plant
The FDA completed an inspection of Shandong Xinhua Pharmaceutical Co., Ltd. FDF Plant on September 20, 2023 in Zibo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zibo (China)
Additional Details
Mutual Recognition Agreement (MRA)