FDA Inspection 1026748 — CCRM Seattle LLC
The FDA completed an inspection of CCRM Seattle LLC on Sep 27, 2017 in Bellevue, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 27, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |