FDA-Inspected Site

Lexia LLC

2 FDA inspections are on record for Lexia LLC in Franklin, United States.

483· Form 483 issued

Franklin, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-29.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Sep 2025 – 29 Sep 2025Human DrugsWLView 483 →
6 Mar 2019 – 7 Mar 2019Human Drugs483View 483 →

Observations on record

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

29 Sep 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Inga M Warr

29 Sep 2025
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Inga M Warr

29 Sep 2025
21 CFR 211.122(a)

Written procedures describing in detail

Cited by Inga M Warr

29 Sep 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Inga M Warr

29 Sep 2025
21 CFR 211.166(a)

Lack of written stability program

Cited by Inga M Warr

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(d)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Lexia 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