FDA Inspection 1204932 — MedDev Manufacturing Sdn Bhd
The FDA completed an inspection of MedDev Manufacturing Sdn Bhd on May 4, 2023 in Klang. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 4, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Klang (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |