Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-04.
At a glance
Inspections
4
Form 483s
2
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2022 – 4 Nov 2022 | Human Drugs | 483 | View 483 → |
| 19 Jan 2018 – 25 Jan 2018 | Human Drugs | Clean | |
| 17 Nov 2015 – 19 Nov 2015 | Human Drugs | Clean | |
| 28 Feb 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2022
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Vivin George, Juliana M Badalucco, Sayyem H Akbar
4 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Vivin George, Juliana M Badalucco, Sayyem H Akbar
Investigators
FDA investigators tied to this site in the record.
Sony Mathews3 insp.
Vivin George1 insp.
Juliana M Badalucco1 insp.
Sayyem H Akbar1 insp.
Charanjeet Jassal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Port Jervis Laboratories, Inc'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