Form 483

3M Company Form 483, 2020-03-20

FDA issued a Form 483 to 3M Company on 2020-03-20 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

3M Company · Saint Paul, United States · Issued March 20, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

20 Mar 2020
21 CFR 211.150

Written distribution procedure

Cited by Scott A Golladay

20 Mar 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Scott A Golladay

20 Mar 2020
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Scott A Golladay

20 Mar 2020
21 CFR 314.81(b)(1)(ii)

Contamination, chemical or physical change, deterioration

Cited by Scott A Golladay

Inspected site

3C3M CompanySaint Paul, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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