Form 483

Robbins Instruments, LLC Form 483, 2026-01-27

FDA issued a Form 483 to Robbins Instruments, LLC on 2026-01-27 with 9 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health9 observations

Robbins Instruments, LLC · Houston, United States · Issued January 27, 2026

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

27 Jan 2026
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Jocelyn C Turner

27 Jan 2026
21 CFR 820.120(b)

Labeling inspection - UDI

Cited by Jocelyn C Turner

27 Jan 2026
21 CFR 820.198(c)

Investigation of device failures

Cited by Jocelyn C Turner

27 Jan 2026
21 CFR 820.200(d)

Service reports - UDI

Cited by Jocelyn C Turner

27 Jan 2026
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Jocelyn C Turner

Inspected site

RIRobbins Instruments, LLCHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.120(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.200(d)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(c)Cited across public-safe Form 483 observations1x
21 CFR 820.80(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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