FDA-Inspected Site

PPL Healthcare LLC

14 FDA inspections are on record for PPL Healthcare LLC in Sellersville, United States.

483· Form 483 issued

Sellersville, United States · Last updated July 10, 2026

Overview

  • 14 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-08.

At a glance

Inspections

14

Form 483s

9

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 May 2026 – 8 May 2026Human Drugs483View 483 →
19 Dec 2022 – 13 Jan 2023Human Drugs483On file
9 Apr 2018 – 24 Apr 2018Human Drugs483View 483 →
18 May 2016 – 3 Jun 2016Human Drugs483On file
21 May 2013 – 5 Jun 2013Human Drugs483On file
19 Jul 2012Not recordedClean
26 Jul 2011Not recorded483View 483 →
28 Apr 2010Not recorded483View 483 →
30 Oct 2008Not recorded483View 483 →
30 Jan 2008Not recorded483On file
7 Dec 2004Not recordedClean
9 Jan 2004Not recordedClean

Observations on record

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

8 May 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by David A Oluwo, Daniel T Lee

8 May 2026
21 CFR 211.166(a)

Written program not followed

Cited by David A Oluwo, Daniel T Lee

8 May 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by David A Oluwo, Daniel T Lee

24 Apr 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Anita R Michael

26 Jul 2011
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Erika V Butler, Thomas E Friel, Temar Q Williams

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 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 111.165(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.70(f)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(12)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)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 PPL Healthcare LLC's 9 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