Warning letter
Toxikon Corporation/Labcorp Bedford LLC: warning letter of Feb 10, 2022
FDA warning letter 623581 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 623581 |
|---|---|
| Company | Toxikon Corporation/Labcorp Bedford LLC |
| Subject | Good Laboratory Practice (GLP) |
| Issue date | Feb 10, 2022 |
| Posted date | Feb 22, 2022 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 58, 58.33(b), 58.35(b)(6) |
| Inspection city | Bedford |
| Inspection ZIP | 01730-2314 |
| Inspection start date | Aug 13, 2021 |
| Letter on fda.gov | fda.gov |
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: