FDA Inspection 745740 — Guam Memorial Hosp Authority
The FDA completed an inspection of Guam Memorial Hosp Authority on August 26, 2011 in Tamuning, GU. 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 26, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tamuning, GU (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 119 | 21 CFR 606.121(h) | Labeling requirements for emergency shipment |
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |