FDA Inspection 1081870 — Winter Haven Hospital, Inc.
The FDA completed an inspection of Winter Haven Hospital, Inc. on Feb 21, 2019 in Winter Haven, FL. 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
- Feb 21, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Winter Haven, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15033 | 21 CFR 610.47(a) | Lookback System [Collecting Establishment] |
| 15064 | 21 CFR 610.46(a) | Lookback System [Collecting Establishment] |
| 18089 | 21 CFR 630.10(f)(4) | Physical Assessment Determination - Pulse |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |