Atlas

FDA-Inspected Site

Libby Laboratories, Inc.

7 FDA inspections are on record for Libby Laboratories, Inc. in Berkeley, United States.

483· Form 483 issued

Berkeley, United States · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-14.

At a glance

Inspections

7

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Mar 2025 – 14 Mar 2025Human DrugsWLView 483 →
5 Nov 2019 – 8 Nov 2019Human DrugsClean
3 Aug 2015 – 6 Aug 2015Human DrugsClean
18 Jan 2012Not recorded483View 483 →
3 May 2010Not recorded483View 483 →
11 Jun 2009Not recordedClean
8 Nov 2001Not recordedClean

Observations on record

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

14 Mar 2025
21 CFR 211.165(b)

Microbiological testing

Cited by Anney Lin, Nathan E Hellman

14 Mar 2025
21 CFR 211.84(a)

Components withheld from use pending release

Cited by Anney Lin, Nathan E Hellman

18 Jan 2012
21 CFR 211.63

Equipment Design, Size and Location

Cited by William V Millar

18 Jan 2012
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by William V Millar

3 May 2010
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by William V Millar

Investigators

FDA investigators tied to this site in the record.

William V Millar3 insp.
Anney Lin1 insp.
Nathan E Hellman1 insp.
Jolanna A Norton1 insp.
John A Gonzalez1 insp.
Rochelle B Young1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Libby Laboratories, Inc.'s 3 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