Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-29.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Jun 2023 – 29 Jun 2023 | Medical Devices & Rad Health | Clean | |
| 5 Dec 2022 – 9 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 30 Jul 2018 – 2 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 12 Jan 2012 | Not recorded | 483 | View 483 → |
| 22 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jan 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Laiza V Garcia1 insp.
Stephen C Smith1 insp.
Brian S Keefer1 insp.
Catherine J Laufmann1 insp.
Edward D Mcdonald1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hudson Respiratory Care Tecate S. de RL de CV'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