Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-29.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 May 2025 – 29 May 2025 | Human Drugs | 483 | View 483 → |
| 13 Nov 2023 – 17 Nov 2023 | Human Drugs | 483 | On file |
| 13 Mar 2023 – 17 Mar 2023 | Human Drugs | 483 | On file |
| 18 Jul 2018 – 25 Jul 2018 | Human Drugs | Clean | |
| 14 Dec 2015 – 22 Dec 2015 | Human Drugs | 483 | On file |
| 21 Jul 2009 | Not recorded | Clean | |
| 12 Sep 2008 | Not recorded | Clean | |
| 23 Jul 2003 | Not recorded | Clean | |
| 9 Nov 2000 | Not recorded | Clean | |
| 4 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2025
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Darren S Brown, Navneet Kaur, Ngozi G Offor
29 May 2025
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Darren S Brown, Navneet Kaur, Ngozi G Offor
29 May 2025
21 CFR 211.166(a)(2)
Stability sample storage conditions described
Cited by Darren S Brown, Navneet Kaur, Ngozi G Offor
29 May 2025
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Darren S Brown, Navneet Kaur, Ngozi G Offor
29 May 2025
21 CFR 211.22(a)
Approve or reject components, products
Cited by Darren S Brown, Navneet Kaur, Ngozi G Offor
Investigators
FDA investigators tied to this site in the record.
Darren S Brown1 insp.
Navneet Kaur1 insp.
Ngozi G Offor1 insp.
Nicholas L Hunt1 insp.
Michael T Cyrus1 insp.
Homero W Aguilar1 insp.
Matthew R Clabeaux1 insp.
Santiago Gallardo Johnson1 insp.
Gam S Zamil1 insp.
Carla J Lundi1 insp.
Lilly O Barton1 insp.
Michael D Garcia1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Universal Packaging Systems, Inc.'s 4 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