Atlas

FDA-Inspected Site

Pace Analytical Inc.

10 FDA inspections are on record for Pace Analytical Inc. in San German, United States.

483· Form 483 issued

San German, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-07.

At a glance

Inspections

10

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Aug 2025 – 7 Aug 2025Human Drugs483View 483 →
18 Mar 2024 – 21 Mar 2024Biologics483View 483 →
31 Oct 2018 – 9 Nov 2018Human Drugs483On file
6 Jul 2015 – 9 Jul 2015Human Drugs483View 483 →
31 Oct 2012Not recordedClean
6 Sep 2011Not recordedClean
26 Jun 2009Not recorded483View 483 →
18 Jul 2006Not recordedClean
3 Aug 2005Not recordedClean
8 Apr 2004Not recordedClean

Observations on record

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

7 Aug 2025
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Santos E Camara

7 Aug 2025
21 CFR 211.160(b)(3)

Drug products-sampling procedures/specifications

Cited by Santos E Camara

21 Mar 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jeremy L Wally

9 Jul 2015
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Noreen Muniz, Steven P Donald

9 Jul 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Noreen Muniz, Steven P Donald

Investigators

FDA investigators tied to this site in the record.

Noreen Muniz2 insp.
Santos E Camara1 insp.
Jeremy L Wally1 insp.
Steven P Donald1 insp.
Pablo Feliciano1 insp.
Patric C Klotzbuecher1 insp.
Lourdes Andujar1 insp.
Adalberto Cajigas1 insp.

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 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Pace Analytical Inc.'s 5 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