Warning letter
Tosoh Bioscience, Inc.: warning letter of Mar 22, 2005
FDA warning letter UCM075331 · San Francisco District Office
Key facts
| Reference number | UCM075331 |
|---|---|
| Company | Tosoh Bioscience, Inc. |
| Subject | Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated |
| Issue date | Mar 22, 2005 |
| Posted date | Mar 22, 2005 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 7.41, 803, 803.42, 806, 807, 803.50(a)(2), 806.2(d), 806.10(a)(1), 820, 820.40, 806.10(b) |
| Country | 3 |
| Inspection city | South San Francisco |
| Inspection ZIP | 94080-7606 |
| Inspection start date | Aug 20, 2004 |
| 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: