Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-19.
At a glance
Inspections
15
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2022 – 19 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2021 – 10 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2019 – 10 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Apr 2018 – 21 May 2018 | Medical Devices & Rad Health | 483 | On file |
| 9 Nov 2015 – 15 Jan 2016 | Medical Devices & Rad Health | 483 | On file |
| 18 Aug 2014 – 3 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 14 Apr 2014 – 8 May 2014 | Medical Devices & Rad Health | WL | On file |
| 1 Jul 2010 | Not recorded | 483 | View 483 → |
| 20 Jun 2010 | Not recorded | Clean | |
| 28 Aug 2008 | Not recorded | Clean | |
| 2 Jul 2008 | Not recorded | 483 | On file |
| 5 May 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2022
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Christine I Shaw, Joshua E Yao
10 Sep 2021
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Daniel J Lahar
10 Jan 2020
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Janet Pulver, Cecily M Jones, Brandon L Blakely
Investigators
FDA investigators tied to this site in the record.
Shaquenta Y Perkins3 insp.
Scott K Zika2 insp.
Sonya L Karsik2 insp.
Christine I Shaw1 insp.
Joshua E Yao1 insp.
Daniel J Lahar1 insp.
Janet Pulver1 insp.
Cecily M Jones1 insp.
Brandon L Blakely1 insp.
Joey V Quitania1 insp.
Virgilio F Pacio1 insp.
Timothy P Lafave1 insp.
Trudy R Papson1 insp.
Yvette E Guillermo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | 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(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Respironics California LLC'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