FDA-Inspected Site

VIANT PUERTO RICO, INC

3 FDA inspections are on record for VIANT PUERTO RICO, INC in Vega Baja, United States.

483· Form 483 issued

Vega Baja, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-19.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 19 Dec 2025Human Drugs483View 483 →
28 Apr 2025 – 2 May 2025Human Drugs483View 483 →
31 May 2017 – 2 Jun 2017Medical Devices & Rad HealthClean

Observations on record

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

19 Dec 2025
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jesse A Vazquez, Jose F Velez

19 Dec 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jesse A Vazquez, Jose F Velez

19 Dec 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Jesse A Vazquez, Jose F Velez

19 Dec 2025
21 CFR 820.50(a)(3)

Acceptable supplier records, inadequate records

Cited by Jesse A Vazquez, Jose F Velez

19 Dec 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Jesse A Vazquez, Jose F Velez

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 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind VIANT PUERTO RICO, INC'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