Overview
- 16 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-21.
At a glance
Inspections
16
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2024 – 21 Oct 2024 | Human Drugs | 483 | View 483 → |
| 3 Aug 2020 – 11 Aug 2020 | Human Drugs | Clean | |
| 17 Jan 2019 – 31 Jan 2019 | Human Drugs | 483 | On file |
| 27 Aug 2018 – 31 Aug 2018 | Human Drugs | Clean | |
| 4 Apr 2017 – 14 Apr 2017 | Human Drugs | 483 | View 483 → |
| 25 Feb 2016 – 10 Mar 2016 | Human Drugs | 483 | On file |
| 2 Mar 2015 – 6 Mar 2015 | Human Drugs | Clean | |
| 5 Jun 2013 – 12 Jun 2013 | Human Drugs | 483 | On file |
| 23 Jan 2012 | Not recorded | 483 | On file |
| 6 Jan 2011 | Not recorded | 483 | View 483 → |
| 8 Oct 2009 | Not recorded | 483 | On file |
| 23 Oct 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Oct 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Josh Renzo N Ramilo, Raihan A Chowdhury, JoshRenzo N Ramilo
21 Oct 2024
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Josh Renzo N Ramilo, Raihan A Chowdhury, JoshRenzo N Ramilo
21 Oct 2024
21 CFR 211.165(e)
Test methods
Cited by Josh Renzo N Ramilo, Raihan A Chowdhury, JoshRenzo N Ramilo
21 Oct 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Josh Renzo N Ramilo, Raihan A Chowdhury, JoshRenzo N Ramilo
21 Oct 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by Josh Renzo N Ramilo, Raihan A Chowdhury, JoshRenzo N Ramilo
Investigators
FDA investigators tied to this site in the record.
Michael R Klapal2 insp.
Josh Renzo N Ramilo1 insp.
Raihan A Chowdhury1 insp.
JoshRenzo N Ramilo1 insp.
Michael Serrano1 insp.
Tonia F Bernard1 insp.
Helen Verdel1 insp.
Monika Borkowska1 insp.
Zakaria I Ganiyu1 insp.
Yvesna C Blaise1 insp.
Guerlain Ulysse1 insp.
Niketa Patel1 insp.
Jose M Cayuela1 insp.
Douglas C Kovacs1 insp.
Nikki S Ramirez1 insp.
Kelli F Dobilas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | 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 |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Leading Pharma, LLC's 8 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