Overview
- 20 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-12.
At a glance
Inspections
20
Form 483s
7
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jun 2026 – 12 Jun 2026 | Human Drugs | 483 | View 483 → |
| 5 Dec 2023 – 7 Dec 2023 | Human Drugs | Clean | |
| 16 Oct 2023 – 23 Oct 2023 | Human Drugs | 483 | View 483 → |
| 22 Jan 2019 – 1 Feb 2019 | Human Drugs | 483 | View 483 → |
| 1 Nov 2018 – 6 Nov 2018 | Human Drugs | 483 | View 483 → |
| 11 Apr 2017 – 21 Apr 2017 | Human Drugs | 483 | View 483 → |
| 21 May 2015 – 4 Jun 2015 | Human Drugs | 483 | On file |
| 16 Dec 2013 – 23 Dec 2013 | Human Drugs | Clean | |
| 1 Nov 2012 | Not recorded | Clean | |
| 13 Oct 2011 | Not recorded | Clean | |
| 16 Nov 2010 | Not recorded | 483 | View 483 → |
| 5 Mar 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Young K Chou
12 Jun 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Vivin George, Young K Chou
Investigators
FDA investigators tied to this site in the record.
Alice S Tsao4 insp.
James A Liubicich3 insp.
Uduak M Inokon2 insp.
Vivin George1 insp.
Young K Chou1 insp.
Benton M Ketron1 insp.
Syeda N Mahazabin1 insp.
Evan Tong1 insp.
Iram R Hassan1 insp.
Joy P Matthias1 insp.
Demitria J Xiradakis1 insp.
Xiaoping Guan1 insp.
Charisse K Green1 insp.
Ann M Stewart1 insp.
Vanessa M Williams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | 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 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Epic Pharma, LLC's 7 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