Overview
- 11 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-26.
At a glance
Inspections
11
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2026 – 26 Feb 2026 | Human Drugs | 483 | View 483 → |
| 12 Mar 2025 – 20 Mar 2025 | Biologics | 483 | View 483 → |
| 9 Aug 2021 – 13 Aug 2021 | Human Drugs | Clean | |
| 24 Feb 2020 – 6 Mar 2020 | Human Drugs | 483 | View 483 → |
| 17 Jun 2019 – 21 Jun 2019 | Human Drugs | 483 | View 483 → |
| 10 Jun 2019 – 14 Jun 2019 | Biologics | 483 | On file |
| 20 Sep 2017 – 27 Sep 2017 | Human Drugs | 483 | On file |
| 7 Nov 2016 – 10 Nov 2016 | Human Drugs | 483 | View 483 → |
| 27 May 2015 – 19 Jun 2015 | Human Drugs | 483 | View 483 → |
| 14 Jan 2014 – 24 Jan 2014 | Human Drugs | 483 | On file |
| 10 Apr 2013 – 3 May 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Feb 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Nicole E Knowlton, Kayla V Sprague, Tammy T Brown
26 Feb 2026
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Nicole E Knowlton, Kayla V Sprague, Tammy T Brown
26 Feb 2026
21 CFR 211.52
Washing and toilet facilities are deficient
Cited by Nicole E Knowlton, Kayla V Sprague, Tammy T Brown
26 Feb 2026
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Nicole E Knowlton, Kayla V Sprague, Tammy T Brown
26 Feb 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicole E Knowlton, Kayla V Sprague, Tammy T Brown
Investigators
FDA investigators tied to this site in the record.
Kayla V Sprague2 insp.
Michael H Tollon2 insp.
Nicole E Knowlton1 insp.
Tammy T Brown1 insp.
Peng Zhou1 insp.
Thai D Truong1 insp.
Joanne E King1 insp.
Lillian M Colon-Mcknight1 insp.
Suzanne N Vallez1 insp.
Jennifer Lalama1 insp.
Yifan Wang1 insp.
Vivin George1 insp.
Jose F Velez1 insp.
Naveen B Kanthamneni1 insp.
Laura Fontan1 insp.
Larry K Hampton1 insp.
Jessica L Pressley1 insp.
Christie A Soto1 insp.
Mizanne E Lewis1 insp.
Joshua J Silvestri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | 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 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CoreRX Inc.'s 10 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