Atlas

Form 483

COMECER NETHERLANDS B.V. Form 483, 2022-09-08

FDA issued a Form 483 to COMECER NETHERLANDS B.V. on 2022-09-08 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

COMECER NETHERLANDS B.V. · Joure, Netherlands · Issued September 8, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

8 Sep 2022
21 CFR 820.250(b)

Sampling plans

Cited by Suyang Qin

8 Sep 2022
21 CFR 820.80(a)

Lack of or inadequate procedures - Acceptance activities

Cited by Suyang Qin

Inspected site

CNCOMECER NETHERLANDS B.V.Joure, Netherlands

Inspection team

SQSuyang Qin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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