Atlas

Form 483

Saris and Things, Inc. Form 483, 2026-06-10

FDA issued a Form 483 to Saris and Things, Inc. on 2026-06-10 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Saris and Things, Inc. · Plainfield, United States · Issued June 10, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

10 Jun 2026
ISO 13485:2016 Clause 4.1.1

QMS not documented and maintained adequately

Cited by Shuana H Xiong

Inspected site

SASaris and Things, Inc.Plainfield, United States

Inspection team

SHShuana H Xiong

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.1Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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