Warning letter
Sun Biomedical Laboratories, Inc.: warning letter of Apr 12, 2007
FDA warning letter UCM076356 · New Jersey District Office
Key facts
| Reference number | UCM076356 |
|---|---|
| Company | Sun Biomedical Laboratories, Inc. |
| Subject | CGMP for Medical Devices/QSR/Adulterated/Misbranded |
| Issue date | Apr 12, 2007 |
| Posted date | Apr 12, 2007 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b), 820 |
| Country | 3 |
| Inspection city | Blackwood |
| Inspection ZIP | 08012-3124 |
| Inspection start date | Apr 3, 2006 |
| 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: