Atlas

FDA-Inspected Site

McNeil Healthcare LLC.

13 FDA inspections are on record for McNeil Healthcare LLC. in Las Piedras, United States.

483· Form 483 issued

Las Piedras, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-09-20.

At a glance

Inspections

13

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Sep 2023 – 20 Sep 2023Human Drugs483On file
9 Mar 2021 – 31 Mar 2021Human Drugs483On file
12 Jun 2018 – 21 Jun 2018Human DrugsClean
17 Mar 2015 – 31 Mar 2015Human DrugsClean
12 Aug 2013 – 27 Aug 2013Human DrugsClean
26 Oct 2011Not recorded483View 483 →
2 Nov 2010Not recorded483View 483 →
3 Feb 2010Not recorded483View 483 →
8 Jan 2010Not recorded483View 483 →
6 Aug 2008Not recorded483On file
23 Feb 2005Not recordedClean
9 Sep 2002Not recordedClean

Observations on record

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

26 Oct 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Libia M Lugo, Jose R Lopez

2 Nov 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jose R Lopez, Rebecca Parrilla

2 Nov 2010
21 CFR 211.67(b)

Written procedures fail to include

Cited by Jose R Lopez, Rebecca Parrilla

2 Nov 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jose R Lopez, Rebecca Parrilla

2 Nov 2010
21 CFR 211.110(a)

Written in-process control procedures

Cited by Jose R Lopez, Rebecca Parrilla

Investigators

FDA investigators tied to this site in the record.

Jose R Lopez4 insp.
Jose E Melendez2 insp.
Marian E Ramirez1 insp.
Jose M Cayuela1 insp.
Ariel Cruz Figueroa1 insp.
German Rivera1 insp.
Dayna I Martinez1 insp.
Libia M Lugo1 insp.
Rebecca Parrilla1 insp.
Ramon A Hernandez1 insp.
Raquel Gonzalez Rivera1 insp.
Jorge L Lajara1 insp.
Iraida Ortiz1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
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 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind McNeil Healthcare LLC.'s 7 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