Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-25.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 25 Sep 2025 | Human Drugs | 483 | View 483 → |
| 11 Oct 2022 – 17 Oct 2022 | Human Drugs | 483 | View 483 → |
| 7 May 2018 – 11 May 2018 | Human Drugs | 483 | On file |
| 7 Jul 2015 – 10 Jul 2015 | Human Drugs | 483 | View 483 → |
| 8 Aug 2014 – 11 Aug 2014 | Human Drugs | Clean | |
| 12 Sep 2012 | Not recorded | Clean | |
| 23 Jun 2011 | Not recorded | 483 | View 483 → |
| 8 Mar 2010 | Not recorded | Clean | |
| 2 Dec 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Sep 2025
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Catherine O Lamptey
17 Oct 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Vivin George, Tanya R Syffrard, Syeda N Mahazabin
17 Oct 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Vivin George, Tanya R Syffrard, Syeda N Mahazabin
Investigators
FDA investigators tied to this site in the record.
Mindy M Chou2 insp.
Sony Mathews2 insp.
Robert C Horan2 insp.
Catherine O Lamptey1 insp.
Vivin George1 insp.
Tanya R Syffrard1 insp.
Syeda N Mahazabin1 insp.
Jay T Wong1 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 | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PML NYC, LLC'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