Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-23.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2025 – 23 May 2025 | Human Drugs | Clean | |
| 31 Aug 2022 – 7 Sep 2022 | Human Drugs | 483 | View 483 → |
| 12 Nov 2018 – 16 Nov 2018 | Human Drugs | Clean | |
| 2 Jul 2018 – 6 Jul 2018 | Human Drugs | 483 | On file |
| 30 Mar 2015 – 3 Apr 2015 | Human Drugs | 483 | On file |
| 14 Dec 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Sep 2022
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Kham Phommachanh
7 Sep 2022
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Kham Phommachanh
Investigators
FDA investigators tied to this site in the record.
Nicholas J Presto1 insp.
Kham Phommachanh1 insp.
Michael L Casner1 insp.
Lindsey M Schwierjohann1 insp.
Justin A Boyd1 insp.
Jose R Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Orient Pharma Co., Ltd.'s 3 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