Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-12-03.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Nov 2024 – 3 Dec 2024 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Dec 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Tamil Arasu, Wayne D Mcgrath, David J Gomes
3 Dec 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Tamil Arasu, Wayne D Mcgrath, David J Gomes
3 Dec 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Wayne D Mcgrath, David J Gomes
3 Dec 2024
21 CFR 211.194(a)
Complete test data included in records
Cited by Tamil Arasu, Wayne D Mcgrath, David J Gomes
3 Dec 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Tamil Arasu, Wayne D Mcgrath, David J Gomes
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vantive Manufacturing (Thailand) Company's 1 Form 483
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