FDA Inspection 1227210 — Landy International
The FDA completed an inspection of Landy International on December 14, 2023 in Xia Men. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 14, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Xia Men (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |