Atlas

Form 483

Pemco Inc Form 483, 2024-10-25

FDA issued a Form 483 to Pemco Inc on 2024-10-25 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Pemco Inc · Independence, United States · Issued October 25, 2024

Overview

  • 2 public-safe observations are 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.

25 Oct 2024
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Benjamin J Dastoli

25 Oct 2024
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Benjamin J Dastoli

Inspected site

PIPemco IncIndependence, United States

Inspection team

BJBenjamin J Dastoli

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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