Atlas

FDA-Inspected Site

ALIEN MILLING TECHNOLOGIES

2 FDA inspections are on record for ALIEN MILLING TECHNOLOGIES in Glendora, United States.

483· Form 483 issued

Glendora, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-25.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Jun 2026 – 25 Jun 2026Medical Devices & Rad Health483View 483 →
17 Nov 2020 – 1 Dec 2020Medical Devices & Rad Health483On file

Observations on record

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

25 Jun 2026
ISO 13485:2016 Clause 4.2.4

Lack of document control

Cited by Linda Galindo

25 Jun 2026
ISO 13485:2016 Clause 5.1

Lack of evidence for top management's commitment to QMS

Cited by Linda Galindo

25 Jun 2026
ISO 13485:2016 Clause 7.1

Processes needed for product realization not planned and developed

Cited by Linda Galindo

25 Jun 2026
ISO 13485:2016 Clause 7.4.1

Procedures for purchasing process not documented

Cited by Linda Galindo

25 Jun 2026
ISO 13485:2016 Clause 7.5.6

Process for production and service provision not validated

Cited by Linda Galindo

Investigators

FDA investigators tied to this site in the record.

Linda Galindo1 insp.
State Agency1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.2.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited 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 ALIEN MILLING TECHNOLOGIES' 2 Form 483s

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