Tris Pharma Inc.
Form 483 issued June 8, 2021 · Monmouth Junction, New Jersey
- Inspection
- May 3 – Jun 8, 2021
- Investigators
- Jay B. Shah· Rose Jean-Mary
- Observations
- 7
- Pages
- 19
- FEI number
- 3004712471
In short: On June 8, 2021, FDA issued a Form 483 with 7 observations to Tris Pharma Inc. in Monmouth Junction, New Jersey (FEI 3004712471) after an inspection that ran May 3 – Jun 8, 2021. The investigators were Jay B. Shah and Rose Jean-Mary. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Jay B. Shah
5 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmTris Pharma Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tris Pharma Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Tris Pharma Inc.?
Jay B. Shah and Rose Jean-Mary are named on this Form 483, for the inspection of May 3 – Jun 8, 2021. Each investigator has a profile showing what they cite most.
When was Tris Pharma Inc. inspected by FDA?
The inspection ran May 3 – Jun 8, 2021, and the Form 483 is dated June 8, 2021.
How do I get the full Form 483 for Tris Pharma Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.