Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-10.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 10 Dec 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Jun 2024 – 21 Jun 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Mar 2023 – 7 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Sep 2021 – 4 Oct 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jul 2017 – 31 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Mar 2013 – 12 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 10 Aug 2010 | Not recorded | Clean | |
| 23 Mar 2008 | Not recorded | Clean | |
| 8 Jun 2006 | Not recorded | Clean | |
| 26 Apr 2004 | Not recorded | Clean | |
| 28 Aug 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2025
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by William R Chang
10 Dec 2025
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by William R Chang
10 Dec 2025
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by William R Chang
Investigators
FDA investigators tied to this site in the record.
William R Chang3 insp.
Frank J Marciniak2 insp.
Naakesh N Gomanie1 insp.
Jonathan Ho1 insp.
Gobiga Vanniyasingam1 insp.
Cynthia L Gorveatt1 insp.
Stephen R Souza1 insp.
Brenda L Reihing1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Next Medical Products Company, LLC's 5 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