Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-21.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 21 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Feb 2018 – 5 Mar 2018 | Medical Devices & Rad Health | 483 | On file |
| 29 Aug 2016 – 31 Aug 2016 | Medical Devices & Rad Health | Clean | |
| 23 Oct 2012 – 25 Feb 2013 | Human Drugs | 483 | View 483 → |
| 3 Aug 2011 | Not recorded | Clean | |
| 21 Apr 2011 | Not recorded | Clean | |
| 2 Nov 2007 | Not recorded | Clean | |
| 18 Apr 2006 | Not recorded | Clean | |
| 20 Dec 2004 | Not recorded | Clean | |
| 25 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Feb 2013
21 CFR 211.22(b)
Adequate lab facilities not available
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
25 Feb 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Julia E Chervoni, Sangeeta M Khurana, Anita Narula, Sharon I Gundersen, Lori J Silverstein, Heika R Tait
Investigators
FDA investigators tied to this site in the record.
Sangeeta M Khurana2 insp.
Lori J Silverstein2 insp.
Heika R Tait2 insp.
Gloria E Andia1 insp.
Paul M Kawamoto1 insp.
Susan T Hadman1 insp.
Andrew K Haack1 insp.
Marijo B Kambere1 insp.
Virgilio F Pacio1 insp.
Julia E Chervoni1 insp.
Anita Narula1 insp.
Sharon I Gundersen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | 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 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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 Pascal Company Inc's 3 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