FDA-Inspected Site

Private Label Partners, Inc.

9 FDA inspections are on record for Private Label Partners, Inc. in Santa Ana, United States.

483· Form 483 issued

Santa Ana, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-17.

At a glance

Inspections

9

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Jan 2025 – 17 Jan 2025Human Drugs483View 483 →
10 Sep 2019 – 13 Sep 2019Human Drugs483View 483 →
14 Jun 2016 – 17 Jun 2016Human Drugs483View 483 →
14 Mar 2012Not recorded483View 483 →
8 Feb 2011Not recorded483On file
13 Jul 2010Not recorded483View 483 →
28 Aug 2007Not recordedClean
18 Dec 2006Not recordedClean
16 Jul 2003Not recordedClean

Observations on record

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

17 Jan 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Andrew Le, Lena Nguyen

17 Jan 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Andrew Le, Lena Nguyen

17 Jan 2025
21 CFR 211.166(a)

Written program not followed

Cited by Andrew Le, Lena Nguyen

17 Jan 2025
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Andrew Le, Lena Nguyen

17 Jan 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Andrew Le, Lena Nguyen

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 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.182Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.80(b)Cited across public-safe Form 483 observations2x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Private Label Partners, Inc.'s 6 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