Tris Pharma Inc.
FDA inspection history in Monmouth Junction, New Jersey, 2018 to 2024
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2018: one close-out letter; 2019: one Form 483; 2021: one close-out letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two close-out letters and two Form 483s, at Monmouth Junction, New Jersey.
- 2021The longest 483 on file: 7 observations over 19 pages at Monmouth Junction, New Jersey.
- 2024One Form 483, at Monmouth Junction, New Jersey.
Cited most
Across all Tris Pharma observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Tris Pharma file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Monmouth Junction, New Jersey
Three Form 483s and two close-out letters · 2018 to 2024 · 11 observations
Latest: Form 483, Mar 8, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-08 | 483 Form 483 | Monmouth Junction, New Jersey | 2 | $99 |
| 2021-12-27 | Close-out Close-out letter | Monmouth Junction, New Jersey | — | $99 |
| 2021-06-08 | 483 Form 483 | Monmouth Junction, New Jersey | 7 | $99 |
| 2019-01-23 | 483 Form 483 | Monmouth Junction, New Jersey | 2 | $99 |
| 2018-03-26 | Close-out Close-out letter | Monmouth Junction, New Jersey | — | $99 |
Investigators on these documents
Jay B. Shah (1)Jose O. Hernandez (1)Rose Jean-Mary (1)Russell J. Glapion (1)Tamil Arasu (1)
FEI number 3004712471 · most recent document Mar 8, 2024
About Tris Pharma Inc.
How many FDA Form 483s has Tris Pharma Inc. received?
FDA Intel has 3 Form 483s on file for Tris Pharma Inc.; the most recent is dated Mar 8, 2024.
When was Tris Pharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for Tris Pharma Inc. is a Form 483 dated Mar 8, 2024, for the site in Monmouth Junction, New Jersey.
What did FDA cite at Tris Pharma Inc.?
The regulations cited most in the observations on file for Tris Pharma Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time.