Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-22.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Nov 2019 – 22 Nov 2019 | Human Drugs | Clean | |
| 15 Jan 2018 – 19 Jan 2018 | Human Drugs | 483 | View 483 → |
| 17 Feb 2014 – 21 Feb 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jan 2018
21 CFR 312.64(c)
Final study report
Cited by Makini Cobourne-Duval, Melkamu Getie Kebtie, Susanne M Richardson
Investigators
FDA investigators tied to this site in the record.
Amanda Lewin1 insp.
Lori Gioia1 insp.
Gajendiran Mahadevan1 insp.
Makini Cobourne-Duval1 insp.
Melkamu Getie Kebtie1 insp.
Susanne M Richardson1 insp.
Xikui Chen1 insp.
Gulshan R Anand1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.64(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Panexcell Clinical Lab PVT. LTD.'s 2 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