FDA Inspection 1006405 — Jiangmen Nowadays Daily Goods Co., Ltd.
The FDA completed an inspection of Jiangmen Nowadays Daily Goods Co., Ltd. on March 9, 2017 in Jiangmen. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jiangmen (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |