Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-07.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2026 – 7 May 2026 | Human Drugs | Clean | |
| 11 Sep 2023 – 18 Sep 2023 | Human Drugs | 483 | On file |
| 13 Sep 2021 – 17 Sep 2021 | Human Drugs | 483 | View 483 → |
| 11 Mar 2020 – 16 Mar 2020 | Human Drugs | Clean | |
| 4 Mar 2019 – 6 Mar 2019 | Human Drugs | Clean | |
| 8 Jan 2019 – 15 Jan 2019 | Human Drugs | Clean | |
| 25 Jan 2018 – 26 Jan 2018 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Arsen Karapetyan, Joseph A Piechocki
17 Sep 2021
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Arsen Karapetyan, Joseph A Piechocki
17 Sep 2021
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Arsen Karapetyan, Joseph A Piechocki
17 Sep 2021
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Arsen Karapetyan, Joseph A Piechocki
17 Sep 2021
21 CFR 211.63
Equipment Design, Size and Location
Cited by Arsen Karapetyan, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Robert J Ham2 insp.
Karen M Montgomery2 insp.
Logan M Jones1 insp.
Monica E Murie1 insp.
Arsen Karapetyan1 insp.
Joseph A Piechocki1 insp.
Ana Paula P Sandee1 insp.
Steven D Kehoe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SpecGx, LLC's 2 Form 483s
Source PDFs 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