Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-30.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2025 – 30 Apr 2025 | Biologics | 483 | View 483 → |
| 1 Mar 2022 – 22 Mar 2022 | Biologics | 483 | View 483 → |
| 30 Aug 2019 – 13 Sep 2019 | Foods & Cosmetics | 483 | View 483 → |
| 25 Mar 2019 – 3 Apr 2019 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Apr 2025
21 CFR 1271.160(a)
All core requirements covered in program
Cited by Laurissa S Flowers, Creighton T Tuzon
30 Apr 2025
21 CFR 1271.180(a)
Procedures to meet core CTGP
Cited by Laurissa S Flowers, Creighton T Tuzon
30 Apr 2025
21 CFR 1271.200(a)
Cleaned, sanitized per established schedules
Cited by Laurissa S Flowers, Creighton T Tuzon
30 Apr 2025
21 CFR 1271.260(a)
Contamination, mix ups, improper release
Cited by Laurissa S Flowers, Creighton T Tuzon
30 Apr 2025
21 CFR 1271.265(c)(1)
Release of HCT/Ps by responsible person
Cited by Laurissa S Flowers, Creighton T Tuzon
Investigators
FDA investigators tied to this site in the record.
Laurissa S Flowers3 insp.
Creighton T Tuzon1 insp.
Garrad R Poole1 insp.
Aneel K Sandhu1 insp.
Alexandra B Pitkin1 insp.
Scott T Ballard1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.290(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 601(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Invitrx Therapeutics Inc.'s 4 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