Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-31.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2025 – 31 Oct 2025 | Human Drugs | Clean | |
| 28 Jun 2023 – 7 Jul 2023 | Human Drugs | 483 | View 483 → |
| 15 Nov 2021 – 19 Nov 2021 | Human Drugs | Clean | |
| 17 Jun 2021 – 25 Jun 2021 | Human Drugs | 483 | On file |
| 24 Aug 2020 – 3 Sep 2020 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jul 2023
21 CFR 211.67(b)
Written procedures fail to include
Cited by Christina K Theodorou, Michael L Casner
Investigators
FDA investigators tied to this site in the record.
Yaharn Su1 insp.
Christina K Theodorou1 insp.
Michael L Casner1 insp.
Russell J Glapion1 insp.
Bryan L Mcguckin1 insp.
Ko U Min1 insp.
Janet A Rajan1 insp.
Frederick Razzaghi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Carnegie Pharmaceuticals, LLC's 3 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