Overview
- 15 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-17.
At a glance
Inspections
15
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2025 – 17 Jan 2025 | Human Drugs | 483 | View 483 → |
| 9 Mar 2020 – 13 Mar 2020 | Human Drugs | Clean | |
| 2 Apr 2018 – 6 Apr 2018 | Human Drugs | Clean | |
| 26 Jan 2016 – 29 Jan 2016 | Human Drugs | 483 | View 483 → |
| 26 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | On file |
| 20 Apr 2012 | Not recorded | 483 | View 483 → |
| 27 Jan 2010 | Not recorded | 483 | View 483 → |
| 27 Jun 2008 | Not recorded | Clean | |
| 22 Jun 2007 | Not recorded | Clean | |
| 16 Jun 2005 | Not recorded | Clean | |
| 18 Feb 2005 | Not recorded | Clean | |
| 16 Dec 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Edmund F Mrak, Lori M Newman, Armen H Youssoufian, Paige R Mccoy
17 Jan 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Edmund F Mrak, Lori M Newman, Armen H Youssoufian, Paige R Mccoy
17 Jan 2025
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Edmund F Mrak, Lori M Newman, Armen H Youssoufian, Paige R Mccoy
17 Jan 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Edmund F Mrak, Lori M Newman, Armen H Youssoufian, Paige R Mccoy
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak1 insp.
Lori M Newman1 insp.
Armen H Youssoufian1 insp.
Paige R Mccoy1 insp.
Sony Mathews1 insp.
Roseline N Boateng1 insp.
Marcia D Fields1 insp.
Mindy M Chou1 insp.
Samina S Khan1 insp.
Demitria J Xiradakis1 insp.
Robert C Horan1 insp.
Chad N Thompson1 insp.
Paul E Stein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(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 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | 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 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SpecGx 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