Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-03.
At a glance
Inspections
10
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2026 – 3 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Sep 2024 – 16 Oct 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jun 2023 – 2 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Jul 2019 – 2 Aug 2019 | Human Drugs | 483 | View 483 → |
| 10 Jan 2018 – 12 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Oct 2017 – 19 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 4 Aug 2015 – 7 Aug 2015 | Medical Devices & Rad Health | Clean | |
| 3 Jan 2013 – 21 Feb 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Nov 2011 | Not recorded | 483 | On file |
| 6 Aug 2010 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Thomas Siebertz, Sunita Pandey
3 Jun 2026
ISO 13485:2016 Clause 7.3.6
Design and development verification plans not documented
Cited by Thomas Siebertz, Sunita Pandey
3 Jun 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not complete prior to release of product
Cited by Thomas Siebertz, Sunita Pandey
3 Jun 2026
ISO 13485:2016 Clause 7.4.1
Criteria for the evaluation and selection of suppliers not established
Cited by Thomas Siebertz, Sunita Pandey
3 Jun 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Thomas Siebertz, Sunita Pandey
Investigators
FDA investigators tied to this site in the record.
Sunita Pandey3 insp.
Maura Rooney2 insp.
Justine M Corson2 insp.
Thomas Siebertz1 insp.
Michael Serrano1 insp.
Michael P Anthony1 insp.
Stephen C Smith1 insp.
MDSAP harperd1 insp.
Dien N Nguyen1 insp.
John A Sciacchitano1 insp.
Arie Menachem1 insp.
Ramon E Martinez1 insp.
Rory Geyer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(f)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 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 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 8 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