Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-08.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2025 – 8 Apr 2025 | Medical Devices & Rad Health | Clean | |
| 3 Mar 2022 – 8 Mar 2022 | Medical Devices & Rad Health | Clean | |
| 19 Jan 2017 – 24 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jan 2016 – 15 Jan 2016 | Medical Devices & Rad Health | Clean | |
| 27 May 2015 – 4 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 5 Aug 2014 – 14 Aug 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 11 Jan 2013 | Not recorded | WL | On file |
| 12 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jan 2017
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Kimberly M Lichter
24 Jan 2017
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Kimberly M Lichter
14 Aug 2014
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Kimberly M Lichter
14 Aug 2014
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Kimberly M Lichter
Investigators
FDA investigators tied to this site in the record.
Kimberly M Lichter4 insp.
State Agency1 insp.
Kirtida Patel1 insp.
Trudy R Papson1 insp.
Deborah A Greco1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alpha Medical Instruments, LLC's 3 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