Atlas

Form 483

PFM Medical Mepro GMBH Form 483, 2023-01-26

FDA issued a Form 483 to PFM Medical Mepro GMBH on 2023-01-26 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

PFM Medical Mepro GMBH · Nonnweiler, Germany · Issued January 26, 2023

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.

26 Jan 2023
21 CFR 803.17(b)(4)

Info which facilitates timely FDA follow-up

Cited by Joshua J Silvestri

26 Jan 2023
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Joshua J Silvestri

Inspected site

PMPFM Medical Mepro GMBHNonnweiler, Germany

Inspection team

JJJoshua J Silvestri

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.90(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