FDA Inspection 1106246 — Transfer Technology, Inc.
The FDA completed an inspection of Transfer Technology, Inc. on Oct 11, 2019 in Huntington Beach, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 12 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 11, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Huntington Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |