Warning letter
Kelyniam Global, Inc.: warning letter of Oct 5, 2017
FDA warning letter 527408 · New England District Office
Key facts
| Reference number | 527408 |
|---|---|
| Company | Kelyniam Global, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 5, 2017 |
| Posted date | Oct 5, 2017 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 807.81(a)(3)(i), 820 |
| Inspection city | Collinsville |
| Inspection ZIP | 06019 |
| Inspection start date | May 10, 2017 |
| 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: