Overview
- 17 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-07.
At a glance
Inspections
17
Form 483s
10
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2025 – 7 Feb 2025 | Animal Drugs & Feeds | Clean | |
| 7 Aug 2024 – 16 Aug 2024 | Human Drugs | 483 | View 483 → |
| 31 Oct 2022 – 4 Nov 2022 | Human Drugs | 483 | View 483 → |
| 1 Nov 2021 – 15 Nov 2021 | Human Drugs | 483 | View 483 → |
| 20 May 2019 – 24 May 2019 | Human Drugs | Clean | |
| 20 Feb 2018 – 1 Mar 2018 | Human Drugs | 483 | View 483 → |
| 25 Apr 2016 – 13 May 2016 | Human Drugs | 483 | View 483 → |
| 10 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 17 Nov 2014 – 21 Nov 2014 | Human Drugs | 483 | View 483 → |
| 22 Jan 2014 – 3 Feb 2014 | Human Drugs | Clean | |
| 15 Jan 2014 – 3 Feb 2014 | Human Drugs | 483 | On file |
| 7 Jan 2013 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Kayla V Sprague, Jessica P Mcalister
16 Aug 2024
21 CFR 211.167(c)
Controlled release dosage form testing
Cited by Kayla V Sprague, Jessica P Mcalister
16 Aug 2024
FDCA 503B(a)(10)(A)
Drug product labels, fails to include
Cited by Kayla V Sprague, Jessica P Mcalister
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton5 insp.
Jennifer A Robinson2 insp.
Kayla V Sprague1 insp.
Jessica P Mcalister1 insp.
Saundrea A Munroe1 insp.
Harshal J Desai1 insp.
Brittny C Cargo1 insp.
Steven A Brettler1 insp.
Laura L Staples1 insp.
Ladislav Kermet1 insp.
Ileana Barreto-Pettit1 insp.
Christos G Tsingelis1 insp.
Christie A Soto1 insp.
Jessica L Pressley1 insp.
Jennifer Lalama1 insp.
Miguel A Martinez1 insp.
Stephanie D Crockett1 insp.
Melanie W Pishnery1 insp.
Melanie G Warzala1 insp.
Tamara M Casselman1 insp.
Michael H Tollon1 insp.
Daveta L Bailey1 insp.
Jose A Lopez Rubet1 insp.
Salvatore N Randazzo1 insp.
Sarah E Mcmullen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 310.305(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Belcher Pharmaceuticals LLC'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