Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-11-08.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2017 – 8 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jun 2015 – 7 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 22 Jun 2015 – 6 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 5 Jan 2012 | Not recorded | Clean | |
| 8 Dec 2010 | Not recorded | Clean | |
| 23 May 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Nov 2017
21 CFR 820.30(h)
Incorrect translation to production specifications
Cited by Christina L Bigham
8 Nov 2017
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Christina L Bigham
8 Nov 2017
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Brigitte K Strelnik2 insp.
Christina L Bigham1 insp.
Brigitte K Hofmann1 insp.
Maribeth G Grattan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Liebel-Flarsheim Company LLC's 1 Form 483
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