Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-22.
At a glance
Inspections
14
Form 483s
7
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 22 Apr 2026 | Animal Drugs & Feeds | 483 | View 483 → |
| 29 Jan 2026 – 6 Feb 2026 | Human Drugs | 483 | View 483 → |
| 1 Apr 2024 – 5 Apr 2024 | Animal Drugs & Feeds | 483 | View 483 → |
| 18 Oct 2021 – 29 Oct 2021 | Human Drugs | 483 | View 483 → |
| 18 Feb 2019 – 21 Feb 2019 | Human Drugs | Clean | |
| 8 Oct 2018 – 10 Oct 2018 | Human Drugs | 483 | On file |
| 12 Mar 2018 – 15 Mar 2018 | Human Drugs | Clean | |
| 11 Dec 2017 – 15 Dec 2017 | Human Drugs | 483 | View 483 → |
| 9 May 2016 – 16 May 2016 | Human Drugs | Clean | |
| 16 Dec 2013 – 20 Dec 2013 | Human Drugs | Clean | |
| 13 May 2013 – 17 May 2013 | Human Drugs | Clean | |
| 23 Mar 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Apr 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sonya M Edmonds, Steven A Brettler
22 Apr 2026
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Sonya M Edmonds, Steven A Brettler
22 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sonya M Edmonds, Steven A Brettler
22 Apr 2026
21 CFR 211.194(a)
Complete test data included in records
Cited by Sonya M Edmonds, Steven A Brettler
Investigators
FDA investigators tied to this site in the record.
Bonita S Chester4 insp.
Larry K Hampton2 insp.
Sonya M Edmonds1 insp.
Steven A Brettler1 insp.
Brandy N Lepage1 insp.
Victoria Spivak1 insp.
Jared P Stevens1 insp.
Rodney L Tinzie1 insp.
Megan T Ziegler1 insp.
Santos E Camara1 insp.
Adam R Cooke1 insp.
Rachael L Cook1 insp.
Steven Fong1 insp.
Laurie Nelson1 insp.
Seneca D Toms1 insp.
Viviana Matta1 insp.
Zhao Wang1 insp.
Joseph F Owens1 insp.
Jason F Chancey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 Alcami Carolinas Corporation's 7 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