Warning letter
Ark Bio Medical Canada Corp: warning letter of Mar 7, 2017
FDA warning letter 516211 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 516211 |
|---|---|
| Company | Ark Bio Medical Canada Corp |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Mar 7, 2017 |
| Posted date | Mar 21, 2017 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 807.81(a)(3), 807.81(b), 807.81(a) |
| Inspection city | North Milton |
| Inspection start date | Jul 14, 2015 |
| 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: