Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-22.
At a glance
Inspections
12
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 22 Aug 2025 | Human Drugs | 483 | On file |
| 9 Jun 2025 – 13 Jun 2025 | Human Drugs | 483 | View 483 → |
| 10 Jan 2023 – 12 Jan 2023 | Human Drugs | 483 | View 483 → |
| 18 May 2016 | Human Drugs | Clean | |
| 2 Mar 2011 | Not recorded | Clean | |
| 4 Feb 2010 | Not recorded | 483 | View 483 → |
| 9 Nov 2007 | Not recorded | Clean | |
| 14 Jul 2005 | Not recorded | Clean | |
| 9 Jan 2004 | Not recorded | Clean | |
| 17 Jun 2003 | Not recorded | Clean | |
| 27 Jul 2000 | Not recorded | Clean | |
| 11 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Vaishali J Patel, JeanClaude Garay
13 Jun 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vaishali J Patel, JeanClaude Garay
13 Jun 2025
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Vaishali J Patel, JeanClaude Garay
13 Jun 2025
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Vaishali J Patel, JeanClaude Garay
13 Jun 2025
21 CFR 211.42(d)
Penicillin processing area not kept separate
Cited by Vaishali J Patel, JeanClaude Garay
Investigators
FDA investigators tied to this site in the record.
Joseph R Lambert3 insp.
Vaishali J Patel2 insp.
JeanClaude Garay1 insp.
Torrey M Ward1 insp.
Eric M Mueller1 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 | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EPM Packaging, 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