FDA Inspection 1241413 — Zhejiang Meimi Technology Co., Ltd.
The FDA completed an inspection of Zhejiang Meimi Technology Co., Ltd. on May 17, 2024 in Jinhua. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 17, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jinhua (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |