FDA Inspection 1220911 — Aqualex Co., Ltd.
The FDA completed an inspection of Aqualex Co., Ltd. on Oct 20, 2023 in Seongnam. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 20, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seongnam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |