FDA Inspection 1171293 — The A.R.T. Institute Of Washington, Inc.
The FDA completed an inspection of The A.R.T. Institute Of Washington, Inc. on Jun 8, 2022 in Bethesda, MD. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Bethesda, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12244 | 21 CFR 1271.55(d)(1)(i) | Documentation of CD testing and labs |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |