FDA Inspection 1023620 — Wecosmetics Co.
The FDA completed an inspection of Wecosmetics Co. on September 1, 2017 in Ansan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ansan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |