Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 1 Aug 2025 | Human Drugs | 483 | View 483 → |
| 9 Jul 2019 – 12 Jul 2019 | Human Drugs | 483 | View 483 → |
| 16 Apr 2014 – 29 Apr 2014 | Human Drugs | 483 | View 483 → |
| 4 Jan 2012 | Not recorded | 483 | View 483 → |
| 8 Jun 2009 | Not recorded | 483 | View 483 → |
| 25 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Kara J Wright
1 Aug 2025
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Vivin George, Kara J Wright
Investigators
FDA investigators tied to this site in the record.
Jennifer Lalama2 insp.
Vivin George1 insp.
Kara J Wright1 insp.
Ariel Cruz Figueroa1 insp.
Tracy J Washington1 insp.
German Rivera1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PE Packaging, LLC's 5 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