FDA Inspection 984201 — Nicklaus Children's Hospital
The FDA completed an inspection of Nicklaus Children's Hospital on August 3, 2016 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 15076 | 21 CFR 610.46(b)(3) | Notify MD, Legal Rep, or Relative of Transf Recip [Consign] |
| 166 | 21 CFR 606.170(a) | Adverse reaction - Disposition of Reports |
| 9225 | 21 CFR 606.171 | Biological product deviation report |