Atlas

FDA-Inspected Site

Highland Laboratories Inc

5 FDA inspections are on record for Highland Laboratories Inc in Mount Angel, United States.

483· Form 483 issued

Mount Angel, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-06.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Feb 2026 – 6 Feb 2026Foods & Cosmetics483View 483 →
30 Jan 2023 – 10 Mar 2023Foods & Cosmetics483View 483 →
18 Oct 2017 – 20 Oct 2017Foods & CosmeticsClean
23 Jun 2015Human DrugsClean
26 Jun 2012Not recordedClean

Observations on record

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

6 Feb 2026
21 CFR 111.10(b)

Hygienic practices

Cited by Gary C Pecic, Kaitlyn R Kornberg, Jean C Colon Lopez, Cynthia L Haley

6 Feb 2026
21 CFR 111.113(a)(1)

Quality control production, process control; material review, disposition

Cited by Gary C Pecic, Kaitlyn R Kornberg, Jean C Colon Lopez, Cynthia L Haley

6 Feb 2026
21 CFR 111.12

Personnel - qualifications

Cited by Gary C Pecic, Kaitlyn R Kornberg, Jean C Colon Lopez, Cynthia L Haley

6 Feb 2026
21 CFR 111.120(b)

Quality control operations - specifications; components, packaging, labels

Cited by Gary C Pecic, Kaitlyn R Kornberg, Jean C Colon Lopez, Cynthia L Haley

6 Feb 2026
21 CFR 111.123(a)(4)

Quality control operations - material review, disposition decision

Cited by Gary C Pecic, Kaitlyn R Kornberg, Jean C Colon Lopez, Cynthia L Haley

Investigators

FDA investigators tied to this site in the record.

Kaitlyn R Kornberg2 insp.
Crystal A Harlan2 insp.
Gary C Pecic1 insp.
Jean C Colon Lopez1 insp.
Cynthia L Haley1 insp.
Jeannine K Wooten1 insp.
Stephanie A Jameson1 insp.
Jeffrey J Leclair1 insp.
Michael S Hudson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.113(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.320(b)Cited across public-safe Form 483 observations2x
21 CFR 111.10(b)Cited across public-safe Form 483 observations1x
21 CFR 111.113(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.120(b)Cited across public-safe Form 483 observations1x
21 CFR 111.123(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)Cited across public-safe Form 483 observations1x
21 CFR 111.155(c)Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.27(a)Cited across public-safe Form 483 observations1x
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.320(a)Cited across public-safe Form 483 observations1x
21 CFR 111.365(i)Cited across public-safe Form 483 observations1x
21 CFR 111.455(c)Cited across public-safe Form 483 observations1x
21 CFR 111.610(a)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Highland Laboratories 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