Overview
- 14 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-25.
At a glance
Inspections
14
Form 483s
9
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 25 Sep 2024 | Human Drugs | 483 | View 483 → |
| 8 Nov 2022 – 10 Feb 2023 | Human Drugs | 483 | View 483 → |
| 28 Mar 2022 – 20 Apr 2022 | Human Drugs | WL | View 483 → |
| 28 Oct 2019 – 15 Nov 2019 | Human Drugs | 483 | View 483 → |
| 3 Jun 2019 – 7 Jun 2019 | Human Drugs | Clean | |
| 5 Nov 2018 – 14 Nov 2018 | Human Drugs | 483 | View 483 → |
| 17 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 16 Apr 2018 – 20 Apr 2018 | Human Drugs | WL | View 483 → |
| 17 Apr 2017 – 21 Apr 2017 | Human Drugs | 483 | View 483 → |
| 9 Jan 2017 – 20 Jan 2017 | Human Drugs | 483 | View 483 → |
| 7 Dec 2016 – 9 Dec 2016 | Human Drugs | Clean | |
| 27 Jun 2016 – 6 Jul 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Sep 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Veronica Fuentes, Joanne E King, Homero W Aguilar
25 Sep 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Veronica Fuentes, Joanne E King, Homero W Aguilar
25 Sep 2024
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Veronica Fuentes, Joanne E King, Homero W Aguilar
25 Sep 2024
21 CFR 211.42(c)(10)(iii)
Air Supply
Cited by Veronica Fuentes, Joanne E King, Homero W Aguilar
25 Sep 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Veronica Fuentes, Joanne E King, Homero W Aguilar
Investigators
FDA investigators tied to this site in the record.
Larry K Hampton4 insp.
Bonita S Chester4 insp.
Sonya M Edmonds3 insp.
Jared P Stevens3 insp.
Seneca D Toms3 insp.
Veronica Fuentes1 insp.
Joanne E King1 insp.
Homero W Aguilar1 insp.
June P Page1 insp.
Jamie L Port1 insp.
Clifton L Randell1 insp.
Melanie M Walker1 insp.
Mary-Jeanet Mcgarry1 insp.
Song Y Lavalais1 insp.
Brandon C Heitmeier1 insp.
Margaret M Annes1 insp.
Saundrea A Munroe1 insp.
Desiree D Clark1 insp.
Demario L Walls1 insp.
Kemejumaka N Opara1 insp.
Jessica L Pressley1 insp.
Abdollah Koolivand1 insp.
Vincent Thomas1 insp.
Nicole A Lloyd1 insp.
Sayeeda Hdabe1 insp.
Rachael L Cook1 insp.
Diane P Goyette1 insp.
Frank Wackes1 insp.
Constance Y Fears1 insp.
Postelle D Birch-Smith1 insp.
Narong Chamkasem1 insp.
Sharna D Pratt1 insp.
Noreen Muniz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nephron Sterile Compounding Center, LLC's 9 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