Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-28.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2025 – 28 Mar 2025 | Human Drugs | 483 | View 483 → |
| 2 Dec 2024 – 6 Dec 2024 | Human Drugs | Clean | |
| 1 Mar 2023 – 13 Mar 2023 | Human Drugs | 483 | View 483 → |
| 29 Sep 2021 – 30 Sep 2021 | Human Drugs | Clean | |
| 20 Oct 2014 – 23 Oct 2014 | Human Drugs | 483 | On file |
| 24 May 2011 | Not recorded | Clean | |
| 14 Aug 2008 | Not recorded | Clean | |
| 4 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2025
21 CFR 211.111
Establishment of time limitations
Cited by Jennifer L Huntington, Karthik M Krishnan, Ju Du
28 Mar 2025
21 CFR 211.166(a)
Lack of written stability program
Cited by Jennifer L Huntington, Karthik M Krishnan, Ju Du
28 Mar 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jennifer L Huntington, Karthik M Krishnan, Ju Du
28 Mar 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jennifer L Huntington, Karthik M Krishnan, Ju Du
Investigators
FDA investigators tied to this site in the record.
Seneca D Toms2 insp.
Jawaid Hamid2 insp.
Jennifer L Huntington1 insp.
Karthik M Krishnan1 insp.
Ju Du1 insp.
Sri Rama Kr Yellela1 insp.
Patty P Kaewussdangkul1 insp.
Brian J Ryan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 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