Overview
- 18 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-31.
At a glance
Inspections
18
Form 483s
13
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2026 – 31 Mar 2026 | Human Drugs | 483 | View 483 → |
| 16 Sep 2025 – 19 Sep 2025 | Medical Devices & Rad Health | Clean | |
| 19 Aug 2024 – 11 Sep 2024 | Human Drugs | 483 | View 483 → |
| 5 May 2021 – 23 Jun 2021 | Human Drugs | WL | On file |
| 2 May 2019 – 28 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Nov 2017 – 1 Dec 2017 | Human Drugs | 483 | View 483 → |
| 30 Nov 2015 – 9 Dec 2015 | Human Drugs | 483 | View 483 → |
| 3 Jun 2013 – 13 Jun 2013 | Medical Devices & Rad Health | Clean | |
| 18 Oct 2011 | Not recorded | 483 | View 483 → |
| 5 Jul 2011 | Not recorded | 483 | View 483 → |
| 20 Apr 2011 | Not recorded | 483 | View 483 → |
| 21 Oct 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2024
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Jonathan G Matrisciano, Erik W Koester, Jenny Sung
11 Sep 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Jonathan G Matrisciano, Erik W Koester, Jenny Sung
11 Sep 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jonathan G Matrisciano, Erik W Koester, Jenny Sung
Investigators
FDA investigators tied to this site in the record.
Mindy M Chou3 insp.
Gregson A Joseph2 insp.
Paul C Mouris2 insp.
Sony Mathews2 insp.
Jonathan Ho1 insp.
Jonathan G Matrisciano1 insp.
Erik W Koester1 insp.
Jenny Sung1 insp.
Lata C Mathew1 insp.
Vivin George1 insp.
Helen B Ricalde1 insp.
Jacqueline S Warner1 insp.
Alice S Tsao1 insp.
Demitria J Xiradakis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Professional Disposables International, Inc.'s 13 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