Overview
- 23 FDA inspections are on record.
- 14 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-05.
At a glance
Inspections
23
Form 483s
14
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 May 2024 – 5 Jun 2024 | Human Drugs | 483 | View 483 → |
| 9 Dec 2019 – 21 Dec 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 May 2019 – 6 Jun 2019 | Human Drugs | 483 | View 483 → |
| 20 Feb 2017 – 24 Mar 2017 | Medical Devices & Rad Health | WL | View 483 → |
| 13 Mar 2015 – 23 Mar 2015 | Human Drugs | 483 | On file |
| 14 Oct 2014 – 25 Nov 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2014 – 21 Feb 2014 | Medical Devices & Rad Health | 483 | On file |
| 26 Sep 2013 – 9 Oct 2013 | Human Drugs | 483 | On file |
| 25 Sep 2013 – 9 Oct 2013 | Human Drugs | 483 | On file |
| 20 Mar 2013 – 29 Apr 2013 | Human Drugs | Clean | |
| 24 Jan 2013 – 4 Mar 2013 | Medical Devices & Rad Health | 483 | On file |
| 13 Feb 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Control procedures to monitor and validate performance
Cited by Robert J Ham, Joohi Castelvetere, Monica C Burgos Garcia, Jacob G Lutz, Karen M Cruz Arenas
Procedures for sterile drug products
Cited by Robert J Ham, Joohi Castelvetere, Monica C Burgos Garcia, Jacob G Lutz, Karen M Cruz Arenas
Scientifically sound laboratory controls
Cited by Robert J Ham, Joohi Castelvetere, Monica C Burgos Garcia, Jacob G Lutz, Karen M Cruz Arenas
Acceptance criteria for sampling & testing
Cited by Robert J Ham, Joohi Castelvetere, Monica C Burgos Garcia, Jacob G Lutz, Karen M Cruz Arenas
Investigations of discrepancies, failures
Cited by Robert J Ham, Joohi Castelvetere, Monica C Burgos Garcia, Jacob G Lutz, Karen M Cruz Arenas
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 11x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Meridian Medical Technologies, LLC's 14 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