FDA Inspection 1009120 — Nanda Co., Ltd.
The FDA completed an inspection of Nanda Co., Ltd. on Mar 31, 2017 in Mapo. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mapo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |