FDA Inspection 662414 — HEALTHIUM MEDTECH LIMITED
The FDA completed an inspection of HEALTHIUM MEDTECH LIMITED on April 23, 2010 in Bangalore. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |