Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-02-01.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2019 – 1 Feb 2019 | Human Drugs | 483 | View 483 → |
| 26 Feb 2018 – 2 Mar 2018 | Human Drugs | Clean | |
| 16 Jun 2014 – 27 Jun 2014 | Human Drugs | Clean | |
| 30 Apr 2010 | Not recorded | Clean | |
| 11 Feb 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Feb 2019
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Diane C Van Leeuwen, Ni A Khin, Marilyn S Babu
Investigators
FDA investigators tied to this site in the record.
Diane C Van Leeuwen1 insp.
Ni A Khin1 insp.
Marilyn S Babu1 insp.
Joel Martinez1 insp.
Allen F Hall1 insp.
Terrance L Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.64(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tran-Johnson, Tram K.'s 1 Form 483
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