Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-06.
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 |
|---|---|---|---|
| 23 Jan 2024 – 6 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 May 2022 – 7 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Nov 2018 – 9 Nov 2018 | Medical Devices & Rad Health | 483 | On file |
| 14 Nov 2017 – 16 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 7 Sep 2016 – 13 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Mar 2014 – 14 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2011 | Not recorded | Clean | |
| 19 Oct 2010 | Not recorded | 483 | On file |
| 10 Sep 2009 | Not recorded | 483 | View 483 → |
| 16 Jun 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2022
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Maida Henesian
Investigators
FDA investigators tied to this site in the record.
Maida Henesian2 insp.
MDSAP harperd2 insp.
Sergio Chavez1 insp.
Samuel K Gibbons1 insp.
Eric M Padgett1 insp.
Francis J Eng1 insp.
Catherine J Laufmann1 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 | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Xintec Corp'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