Atlas

Form 483

Filmecc Development Center Form 483, 2025-01-23

FDA issued a Form 483 to Filmecc Development Center on 2025-01-23 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Filmecc Development Center · Seto, Japan · Issued January 23, 2025

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

23 Jan 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Joshua J Silvestri

23 Jan 2025
21 CFR 820.30(g)

Design validation- Lack of or inadequate procedures

Cited by Joshua J Silvestri

23 Jan 2025
21 CFR 820.50(a)(3)

Acceptable supplier records, inadequate records

Cited by Joshua J Silvestri

Inspected site

FDFilmecc Development CenterSeto, Japan

Inspection team

JJJoshua J Silvestri

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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