Warning letter
Tris Pharma Inc.: warning letter of Mar 26, 2018
FDA warning letter 534537 · New Jersey District Office
Key facts
| Reference number | 534537 |
|---|---|
| Company | Tris Pharma Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 26, 2018 |
| Posted date | Mar 26, 2018 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 211.34, 211.192 |
| Inspection city | Monmouth Junction |
| Inspection ZIP | 08852 |
| Inspection start date | Feb 14, 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: