Overview
- 15 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-23.
At a glance
Inspections
15
Form 483s
3
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2025 – 23 Apr 2025 | Human Drugs | Clean | |
| 18 Nov 2024 – 31 Dec 2024 | Human Drugs | Clean | |
| 16 Aug 2023 | Tobacco Products | Clean | |
| 16 Nov 2021 – 18 Nov 2021 | Foods & Cosmetics | Clean | |
| 4 Feb 2020 – 6 Feb 2020 | Tobacco Products | Clean | |
| 7 Nov 2018 – 13 Nov 2018 | Human Drugs | 483 | View 483 → |
| 25 Sep 2018 – 27 Sep 2018 | Tobacco Products | Clean | |
| 12 Sep 2014 – 17 Sep 2014 | Human Drugs | 483 | View 483 → |
| 24 Aug 2012 | Not recorded | 483 | View 483 → |
| 10 Aug 2011 | Not recorded | Clean | |
| 4 Jun 2010 | Not recorded | Clean | |
| 22 Mar 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2018
21 CFR 211.194(a)(8)
Identification of Person Performing Review of Lab Records
Cited by Jose O Hernandez
17 Sep 2014
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Sony Mathews, Mindy M Chou
17 Sep 2014
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sony Mathews, Mindy M Chou
Investigators
FDA investigators tied to this site in the record.
Jason D Tenney2 insp.
Sony Mathews2 insp.
Neil J Bonzagni2 insp.
Adena S Yau1 insp.
Roberto A Dookhan1 insp.
Christopher S Fields1 insp.
Jose O Hernandez1 insp.
Arthur G Hurst1 insp.
Wayne S Fortenberry1 insp.
Mindy M Chou1 insp.
Robert C Horan1 insp.
James A Liubicich1 insp.
Frank Verni1 insp.
Thomas J Mooney1 insp.
Charisse K Green1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | 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)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind P & L Development, LLC's 3 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