Warning letter
Bayshore Community Hospital: warning letter of Jun 28, 2001
FDA warning letter UCM178248 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM178248 |
|---|---|
| Company | Bayshore Community Hospital |
| Subject | Institutional Review Board |
| Issue date | Jun 28, 2001 |
| Posted date | Jun 28, 2001 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 56, 56.108, 56.108(b), 56.115(a)(2), 56.115(a)(5), 56.115(a)(6) |
| Country | 3 |
| Inspection city | Holmdel |
| Inspection ZIP | 07733-1514 |
| Inspection start date | Apr 23, 2001 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: