FDA Inspection 1253787 — Englewood Lab Korea Co., Ltd.
The FDA completed an inspection of Englewood Lab Korea Co., Ltd. on October 25, 2024 in Namdong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Namdong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |