FDA Inspection 872796 — Ningbo Pulisi Daily Chemical Products Co., Ltd
The FDA completed an inspection of Ningbo Pulisi Daily Chemical Products Co., Ltd on Mar 21, 2014 in Yuyao City. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yuyao City (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |