FDA Inspection 1265725 — Taizhou Kangping Medical Science And Technology Co., Ltd.
The FDA completed an inspection of Taizhou Kangping Medical Science And Technology Co., Ltd. on Mar 14, 2025 in Taizhou. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taizhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |