Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 21 May 2026 | Human Drugs | 483 | On file |
| 12 Sep 2022 – 20 Sep 2022 | Human Drugs | 483 | On file |
| 1 Sep 2017 – 11 Sep 2017 | Human Drugs | WL | View 483 → |
| 15 May 2017 – 18 May 2017 | Medical Devices & Rad Health | 483 | On file |
| 26 May 2014 – 30 May 2014 | Human Drugs | 483 | On file |
| 26 Aug 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2017
21 CFR 211.180(e)(1)
Representative Number of Batches for Annual Review
Cited by Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Junho Pak1 insp.
Wayne D Mcgrath1 insp.
Ileana Barreto-Pettit1 insp.
Ashley A Mutawakkil1 insp.
Scott T Ballard1 insp.
James C Maclaughlin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TAIWAN BIOTECH CO., LTD.'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