FDA Inspection 1011380 — LEADERS COSMETICS CO.,LTD.
The FDA completed an inspection of LEADERS COSMETICS CO.,LTD. on April 7, 2017 in Anseong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |