FDA Inspection 1080318 — KM PHARMACEUTICAL CO., LTD.
The FDA completed an inspection of KM PHARMACEUTICAL CO., LTD. on Feb 22, 2019 in Pyeongtaek. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pyeongtaek (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |