Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-01.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 1 Dec 2022 | Human Drugs | Clean | |
| 16 Apr 2018 – 25 May 2018 | Human Drugs | 483 | View 483 → |
| 29 Mar 2017 – 30 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2016 – 4 Nov 2016 | Foods & Cosmetics | 483 | On file |
| 26 Feb 2014 – 28 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jul 2013 – 7 Aug 2013 | Human Drugs | Clean | |
| 15 Jul 2011 | Not recorded | Clean | |
| 16 Mar 2010 | Not recorded | 483 | View 483 → |
| 31 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2014
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Stephen R Souza
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza2 insp.
Sangeeta M Khurana2 insp.
Nathaniel B Phillips Sylvain1 insp.
Gloria J Baca1 insp.
Dennis R Hudson1 insp.
Bryce E Mansfield1 insp.
Heika R Tait1 insp.
Dennis G Kawabata1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | 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 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Silgan Unicep 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