FDA-Inspected Site

Benuvia Operations, LLC

5 FDA inspections are on record for Benuvia Operations, LLC in Round Rock, United States.

483· Form 483 issued

Round Rock, United States · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-23.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Jan 2026 – 23 Jan 2026Human Drugs483View 483 →
10 Sep 2021 – 20 Sep 2021Human DrugsClean
12 Feb 2018 – 16 Feb 2018Human Drugs483View 483 →
21 Aug 2017 – 12 Sep 2017Human Drugs483On file
11 Jan 2016 – 12 Jan 2016Human DrugsClean

Observations on record

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

23 Jan 2026
21 CFR 211.194(a)

Complete test data included in records

Cited by Timothy H Vo

23 Jan 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Timothy H Vo

23 Jan 2026
FDCA 582(b)(4)

Systems in place to comply with verification requirements

Cited by Timothy H Vo

16 Feb 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Stephen D Brown

16 Feb 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Stephen D Brown

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 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
FDCA 582(b)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Benuvia Operations, LLC's 3 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