Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Mar 2026 – 2 Apr 2026 | Human Drugs | 483 | View 483 → |
| 10 Jun 2024 – 14 Jun 2024 | Human Drugs | 483 | On file |
| 29 Nov 2021 – 1 Dec 2021 | Foods & Cosmetics | Clean | |
| 30 Mar 2017 – 31 Mar 2017 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.63
Equipment Design, Size and Location
Cited by Crystal Monroy, Carolina D Vasquez
Investigators
FDA investigators tied to this site in the record.
Crystal Monroy1 insp.
Carolina D Vasquez1 insp.
Khoa Nathan V Tran1 insp.
Andrew Le1 insp.
Navneet Kaur1 insp.
Jessica B Clark1 insp.
Abigail A Anderson1 insp.
Jessica B Zachman1 insp.
Stephen R Souza1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Silgan Unicep Packaging, LLC's 2 Form 483s
Source PDFs 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