Atlas

FDA-Inspected Site

PF Consumer Healthcare BV (Puerto Rico Operations) LLC

11 FDA inspections are on record for PF Consumer Healthcare BV (Puerto Rico Operations) LLC in Guayama, United States.

483· Form 483 issued

Guayama, United States · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-14.

At a glance

Inspections

11

Form 483s

8

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Oct 2025 – 14 Oct 2025Human Drugs483View 483 →
29 Apr 2024 – 13 May 2024Foods & Cosmetics483View 483 →
29 Apr 2024 – 3 May 2024Foods & CosmeticsClean
1 Mar 2021 – 17 Mar 2021Human Drugs483View 483 →
2 Jul 2019 – 16 Jul 2019Foods & CosmeticsClean
9 Aug 2018 – 17 Aug 2018Human Drugs483View 483 →
17 Oct 2016 – 25 Oct 2016Human DrugsClean
14 Oct 2014 – 17 Nov 2014Human Drugs483On file
11 Jul 2012Not recorded483On file
8 Mar 2011Not recorded483On file
5 Feb 2010Not recorded483On file

Observations on record

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

14 Oct 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jose F Velez, Marian E Ramirez

14 Oct 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Jose F Velez, Marian E Ramirez

14 Oct 2025
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Jose F Velez, Marian E Ramirez

13 May 2024
21 CFR 111.365(i)

Metal, foreign material

Cited by Jose Perez-Soto

17 Mar 2021
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jose F Velez, Miguel A Martinez

Investigators

FDA investigators tied to this site in the record.

Jose F Velez3 insp.
Jose Perez-Soto3 insp.
Marian E Ramirez1 insp.
Miguel A Martinez1 insp.
Ariel Cruz Figueroa1 insp.
Jose R Lopez1 insp.
Brenda Rivera1 insp.
Dayna I Martinez1 insp.
Jose E Melendez1 insp.
Eva I Merced Medina1 insp.
Milva E Melendez1 insp.

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 314.81(b)(1)(ii)Cited across public-safe Form 483 observations2x
21 CFR 111.365(i)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)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 this site'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