Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-12.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2024 – 12 Apr 2024 | Human Drugs | 483 | View 483 → |
| 27 May 2019 – 31 May 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | 483 | View 483 → |
| 1 Jun 2015 – 4 Jun 2015 | Human Drugs | 483 | On file |
| 11 Mar 2013 – 14 Mar 2013 | Human Drugs | 483 | On file |
| 16 Aug 2012 | Not recorded | Clean | |
| 11 Feb 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2024
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by James R Birkenstamm
Investigators
FDA investigators tied to this site in the record.
James R Birkenstamm1 insp.
Joshua P Wireman1 insp.
Jessica L Pressley1 insp.
Heriberto Negron-Rivera1 insp.
Stephanie C Mangigian1 insp.
James C Maclaughlin1 insp.
Jose R Hernandez1 insp.
Peter C Chow1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lotus Pharmaceutical Co., Ltd. Nantou Plant's 5 Form 483s
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