Overview
- 15 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
15
Form 483s
12
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2025 – 21 Nov 2025 | Human Drugs | 483 | View 483 → |
| 4 Mar 2024 – 8 Mar 2024 | Human Drugs | 483 | View 483 → |
| 3 May 2021 – 8 Jun 2021 | Human Drugs | 483 | View 483 → |
| 9 Jan 2019 – 23 Jan 2019 | Human Drugs | 483 | View 483 → |
| 5 Apr 2018 – 16 Apr 2018 | Human Drugs | 483 | View 483 → |
| 14 Feb 2017 – 20 Mar 2017 | Human Drugs | WL | View 483 → |
| 22 Jan 2016 – 27 Jan 2016 | Human Drugs | Clean | |
| 6 Aug 2015 – 12 Aug 2015 | Human Drugs | 483 | View 483 → |
| 22 Sep 2014 – 1 Oct 2014 | Human Drugs | 483 | On file |
| 6 Jan 2014 – 21 Jan 2014 | Human Drugs | 483 | On file |
| 15 Jun 2012 | Not recorded | 483 | On file |
| 16 Aug 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2024
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Michael Serrano, Emily A Baldwin, Asia D Clark
8 Mar 2024
21 CFR 314.80(d)
Failure to submit scientific article
Cited by Michael Serrano, Emily A Baldwin, Asia D Clark
8 Jun 2021
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Adetutu M Gidado, Yvins Dezan, Jogy George, Rose L Jean-Mary, Jay B Shah
8 Jun 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Adetutu M Gidado, Yvins Dezan, Jogy George, Rose L Jean-Mary, Jay B Shah
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy3 insp.
Addam S Reynolds3 insp.
Adetutu M Gidado2 insp.
Russell J Glapion2 insp.
James R Birkenstamm1 insp.
Michael Serrano1 insp.
Emily A Baldwin1 insp.
Asia D Clark1 insp.
Yvins Dezan1 insp.
Jogy George1 insp.
Rose L Jean-Mary1 insp.
Jay B Shah1 insp.
Tamil Arasu1 insp.
Jose O Hernandez1 insp.
Marcelo O Mangalindan1 insp.
Frederick Razzaghi1 insp.
Loretta Nemchik1 insp.
Nicholas A Violand1 insp.
Juanita P Versace1 insp.
Erin D Mccaffery1 insp.
Maria Estrella1 insp.
Atul Agrawal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tris Pharma Inc.'s 12 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat