Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-23.
At a glance
Inspections
5
Form 483s
2
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 May 2025 – 23 May 2025 | Human Drugs | Clean | |
| 25 Feb 2019 – 5 Mar 2019 | Medical Devices & Rad Health | 483 | On file |
| 17 Dec 2013 – 19 Dec 2013 | Human Drugs | Clean | |
| 21 Oct 2011 | Not recorded | 483 | On file |
| 4 May 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2019
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Lauren N Howard, Teresa K Kastner
5 Mar 2019
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Lauren N Howard, Teresa K Kastner
Investigators
FDA investigators tied to this site in the record.
Joshua S Hunt2 insp.
WenNing Chan1 insp.
Lauren N Howard1 insp.
Teresa K Kastner1 insp.
Nicholas L Paulin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Universal Packaging Systems, Inc.'s 2 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