Warning letter
Tarmac Products, Inc.: warning letter of Nov 9, 2020
FDA warning letter 595993 · Division of Medical Device and Radiological Health Operations Central
Key facts
| Reference number | 595993 |
|---|---|
| Company | Tarmac Products, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 9, 2020 |
| Posted date | Mar 30, 2021 |
| Issuing office | Division of Medical Device and Radiological Health Operations Central |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.34, 211.192, 350, 211.68(a), 211.160(b), 211.166(a), 211.194(a), 350.10(a), 820 |
| Inspection city | Miami Gardens |
| Inspection ZIP | 33014 |
| Inspection start date | Sep 9, 2019 |
| Letter on fda.gov | fda.gov |
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: