FDA Inspection 1233025 — Taiji Medical Supplies Inc.
The FDA completed an inspection of Taiji Medical Supplies Inc. on Mar 15, 2024 in Lincolnton, NC. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lincolnton, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 4061 | 21 CFR 820.20(b)(3)(ii) | Management representative's reports |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |