Warning letter
Access Bio, Inc. [ARCHIVED]: warning letter of Dec 22, 2010
FDA warning letter 121589 · New Jersey District Office
Key facts
| Reference number | 121589 |
|---|---|
| Company | Access Bio, Inc. [ARCHIVED] |
| Subject | Lacks Premarket Approval/Adulterated |
| Issue date | Dec 22, 2010 |
| Posted date | Dec 22, 2010 |
| Issuing office | New Jersey District Office |
| Product type | Biologics |
| CFR sections cited | 820, 820.40, 807.81(b) |
| Inspection city | Somerset |
| Inspection ZIP | 08873 |
| Inspection start date | Aug 4, 2010 |
| 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: