FDA-Inspected Site

LGM Pharma Solutions, LLC

4 FDA inspections are on record for LGM Pharma Solutions, LLC in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-18.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 May 2026 – 18 May 2026Human Drugs483View 483 →
21 Jan 2025 – 24 Jan 2025Human DrugsClean
21 Feb 2024 – 1 Mar 2024Human Drugs483View 483 →
27 Jan 2020 – 31 Jan 2020Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

18 May 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Walden H Lee, Thuy Tram L Nguyen, Jay-Ar C Bendo, Devisree P Mattigiri, Journey V Cordero

18 May 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Walden H Lee, Thuy Tram L Nguyen, Jay-Ar C Bendo, Devisree P Mattigiri, Journey V Cordero

18 May 2026
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Walden H Lee, Thuy Tram L Nguyen, Jay-Ar C Bendo, Devisree P Mattigiri, Journey V Cordero

18 May 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Walden H Lee, Thuy Tram L Nguyen, Jay-Ar C Bendo, Devisree P Mattigiri, Journey V Cordero

1 Mar 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Christopher R Czajka, Roger F Zabinski

Investigators

FDA investigators tied to this site in the record.

Jay-Ar C Bendo1 insp.
Devisree P Mattigiri1 insp.
Journey V Cordero1 insp.
Lan T Tran1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LGM Pharma Solutions, LLC'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