Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2020-02-20.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2020 – 20 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 26 Jun 2009 | Not recorded | Clean | |
| 5 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2020
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Richard K Vogel
20 Feb 2020
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Richard K Vogel
20 Feb 2020
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Richard K Vogel
Investigators
FDA investigators tied to this site in the record.
Leo J Lagrotte2 insp.
Richard K Vogel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | 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 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Encore, Inc.'s 1 Form 483
Source PDFs 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