FDA Inspection 1210508 — S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED
The FDA completed an inspection of S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED on July 21, 2023 in Si Racha. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Si Racha (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |