Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-04.
At a glance
Inspections
12
Form 483s
5
EIRs
6
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Oct 2024 – 4 Oct 2024 | Human Drugs | 483 | On file |
| 14 Jan 2020 – 16 Jan 2020 | Human Drugs | Clean | |
| 22 Mar 2017 – 28 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 Jan 2015 – 14 Jan 2015 | Human Drugs | 483 | View 483 → |
| 23 Jan 2014 – 31 Jan 2014 | Human Drugs | 483 | View 483 → |
| 20 Aug 2012 | Not recorded | Clean | |
| 3 Feb 2012 | Not recorded | 483 | View 483 → |
| 20 Nov 2009 | Not recorded | Clean | |
| 18 May 2007 | Not recorded | Clean | |
| 17 Jun 2005 | Not recorded | Clean | |
| 8 May 2003 | Not recorded | Clean | |
| 7 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Michele L Obert2 insp.
Steven D Kehoe2 insp.
Robert J Ham1 insp.
Mary L Schuckmann1 insp.
Lisa L Flores1 insp.
Jill J Tillman1 insp.
Tiara N Brown-Crosen1 insp.
Dawn C Olenjack1 insp.
Anthony Bucks1 insp.
Tonya R Johnson1 insp.
Susanna E Ford1 insp.
Sina Shojaee1 insp.
Michele Perry Williams1 insp.
Michael D Porter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alcami Carolinas Corporation'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