FDA Inspection 1162488 — Grifols Diagnostic Solutions, INC.
The FDA completed an inspection of Grifols Diagnostic Solutions, INC. on Feb 17, 2022 in San Diego, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 17, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |