FDA Inspection 1014013 — Amaros Co., Ltd
The FDA completed an inspection of Amaros Co., Ltd on May 12, 2017 in Seongnam. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seongnam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3605 | 21 CFR 211.160(b)(1) | Specification description of sample/testing |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |