FDA Inspection 992398 — Ningbo Pulisi Daily Chemical Products Co., Ltd
The FDA completed an inspection of Ningbo Pulisi Daily Chemical Products Co., Ltd on October 21, 2016 in Yuyao City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 21, 2016
- Fiscal Year
- 2017
- 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 |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |