Warning letter
B. Braun Medical Inc: warning letter of Oct 12, 2005
FDA warning letter UCM075607 · New Jersey District Office
Key facts
| Reference number | UCM075607 |
|---|---|
| Company | B. Braun Medical Inc |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Oct 12, 2005 |
| Posted date | Oct 12, 2005 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 7.3(m), 803, 806, 803.50(a)(2), 806.2(i), 806.10(a)(1), 807.81(a)(3)(i), 820, 803.50(b)(3), 807.81(b) |
| Country | 3 |
| Inspection city | Cherry Hill |
| Inspection ZIP | 08003-2016 |
| Inspection start date | May 9, 2005 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: