Tris Pharma Inc.
Form 483 issued January 23, 2019 · Monmouth Junction, New Jersey
- Inspection
- Jan 9 – Jan 23, 2019
- Investigators
- Jose O. Hernandez· Russell J. Glapion· Tamil Arasu
- Observations
- 2
- Pages
- 4
- FEI number
- 3004712471
In short: On January 23, 2019, FDA issued a Form 483 with 2 observations to Tris Pharma Inc. in Monmouth Junction, New Jersey (FEI 3004712471) after an inspection that ran Jan 9 – Jan 23, 2019. The investigators were Jose O. Hernandez, Russell J. Glapion and Tamil Arasu. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.166(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The written stability testing…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tris Pharma Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Tris Pharma Inc.?
Jose O. Hernandez, Russell J. Glapion and Tamil Arasu are named on this Form 483, for the inspection of Jan 9 – Jan 23, 2019. Each investigator has a profile showing what they cite most.
When was Tris Pharma Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 23, 2019, and the Form 483 is dated January 23, 2019.
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.