Tris Pharma Inc.
Form 483 issued March 8, 2024 · Monmouth Junction, New Jersey
- Inspection
- Mar 4 – Mar 8, 2024
- Observations
- 2
- Pages
- 2
- FEI number
- 3004712471
In short: On March 8, 2024, FDA issued a Form 483 with 2 observations to Tris Pharma Inc. in Monmouth Junction, New Jersey (FEI 3004712471) after an inspection that ran Mar 4 – Mar 8, 2024. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy…
- 02
Written procedures have not been developed for the surveillance and reporting to FDA of post…
This inspection in context
Questions about this 483
What did FDA find at Tris Pharma Inc.?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
When was Tris Pharma Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 8, 2024, and the Form 483 is dated March 8, 2024.
How do I get the full Form 483 for Tris Pharma Inc.?
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