Form 483

Millar, Inc. Form 483, 2025-07-01

FDA issued a Form 483 to Millar, Inc. on 2025-07-01 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Millar, Inc. · Houston, United States · Issued July 1, 2025

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Jul 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ellen J Tave

1 Jul 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ellen J Tave

1 Jul 2025
21 CFR 820.22

Quality Audits - defined intervals

Cited by Ellen J Tave

1 Jul 2025
21 CFR 820.22

Quality Audits - defined intervals

Cited by Ellen J Tave

1 Jul 2025
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Ellen J Tave

Inspected site

MIMillar, Inc.Houston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere