Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-28.
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 |
|---|---|---|---|
| 27 Feb 2024 – 28 Feb 2024 | Medical Devices & Rad Health | Clean | |
| 16 Apr 2019 – 17 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 10 Mar 2015 – 28 Apr 2015 | Medical Devices & Rad Health | 483 | On file |
| 3 Aug 2011 | Not recorded | 483 | View 483 → |
| 10 Nov 2005 | Not recorded | Clean | |
| 28 Feb 2002 | Not recorded | Clean | |
| 15 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Aug 2011
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Leo J Lagrotte, Melanie G Warzala
3 Aug 2011
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Leo J Lagrotte, Melanie G Warzala
3 Aug 2011
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Leo J Lagrotte, Melanie G Warzala
Investigators
FDA investigators tied to this site in the record.
Alex J Wild1 insp.
Laiza V Garcia1 insp.
Bill Tackett1 insp.
Leo J Lagrotte1 insp.
Melanie G Warzala1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Benz Research And Development Corporation's 2 Form 483s
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