Warning letter
PETNET Solutions Inc.: warning letter of Oct 17, 2019
FDA warning letter 584016 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 584016 |
|---|---|
| Company | PETNET Solutions Inc. |
| Subject | CGMP/Positron Emission Tomography (PET) Drugs/Adulterated |
| Issue date | Oct 17, 2019 |
| Posted date | Oct 29, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 212.30(a), 212.60(a), 212 |
| Inspection city | Woburn |
| Inspection ZIP | 1801 |
| Inspection start date | Mar 19, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: