Atlas

FDA-Inspected Site

Pro-Tech Design & Manufacturing, Inc.

7 FDA inspections are on record for Pro-Tech Design & Manufacturing, Inc. in Santa Fe Springs, United States.

483· Form 483 issued

Santa Fe Springs, 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 2026-04-02.

At a glance

Inspections

7

Form 483s

3

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Mar 2026 – 2 Apr 2026Medical Devices & Rad Health483View 483 →
23 Jun 2025 – 27 Jun 2025Medical Devices & Rad Health483View 483 →
15 Mar 2022 – 16 Mar 2022Medical Devices & Rad HealthClean
12 Mar 2018 – 16 Mar 2018Medical Devices & Rad HealthClean
27 Jul 2016Medical Devices & Rad HealthClean
15 May 2014 – 12 Jun 2014Medical Devices & Rad Health483On file
23 Sep 2004Not recordedClean

Observations on record

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

2 Apr 2026
ISO 13485:2016 Clause 6.4.1

Work environment requirements and procedures not documented

Cited by Katelyn A Staub-Zamperini, Alexandria L Capuano

2 Apr 2026
ISO 13485:2016 Clause 7.5.1

Production controls not adequate

Cited by Katelyn A Staub-Zamperini, Alexandria L Capuano

2 Apr 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling records not maintained

Cited by Katelyn A Staub-Zamperini, Alexandria L Capuano

2 Apr 2026
ISO 13485:2016 Clause 8.3.1

Records of nonconforming product and actions taken not maintained

Cited by Katelyn A Staub-Zamperini, Alexandria L Capuano

2 Apr 2026
ISO 13485:2016 Clause 8.3.2

Nonconforming product concessions accepted without meeting requirements

Cited by Katelyn A Staub-Zamperini, Alexandria L Capuano

Investigators

FDA investigators tied to this site in the record.

Katelyn A Staub-Zamperini1 insp.
Alexandria L Capuano1 insp.
Kevin N Tran1 insp.
Marlo-Ian M Alintanahin1 insp.
Janet Pulver1 insp.
Jocelyn E Massey1 insp.
Eileen T Dupont1 insp.
Juanita Banuelos1 insp.
Durell L Giles1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Pro-Tech Design & Manufacturing, Inc.'s 3 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