Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-14.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 – 14 May 2026 | Medical Devices & Rad Health | Clean | |
| 10 Apr 2019 – 23 Apr 2019 | Human Drugs | 483 | View 483 → |
| 14 Dec 2018 – 18 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 14 May 2013 – 17 May 2013 | Medical Devices & Rad Health | Clean | |
| 21 Sep 2010 | Not recorded | 483 | View 483 → |
| 28 Jun 2006 | Not recorded | Clean | |
| 13 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2019
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Robert J Martin, Jonah S Ufferfilge
23 Apr 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Robert J Martin, Jonah S Ufferfilge
23 Apr 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Robert J Martin, Jonah S Ufferfilge
23 Apr 2019
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Robert J Martin, Jonah S Ufferfilge
23 Apr 2019
21 CFR 211.170(a)
Active ingredient retained sample kept
Cited by Robert J Martin, Jonah S Ufferfilge
Investigators
FDA investigators tied to this site in the record.
Eric C Schmitt2 insp.
Robert J Martin1 insp.
Jonah S Ufferfilge1 insp.
Jonathan G Matrisciano1 insp.
Dawn M Braswell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alden Medical LLC's 2 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