Form 483

Stericycle Inc Form 483, 2024-02-12

FDA issued a Form 483 to Stericycle Inc on 2024-02-12 with 7 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health7 observations

Stericycle Inc · Bannockburn, United States · Issued February 12, 2024

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

12 Feb 2024
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Brittani N Franklin

12 Feb 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Brittani N Franklin

12 Feb 2024
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Brittani N Franklin

12 Feb 2024
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Brittani N Franklin

12 Feb 2024
21 CFR 820.250(b)

Sampling methods - Lack of or inadequate procedures

Cited by Brittani N Franklin

Inspected site

SIStericycle IncBannockburn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.250(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)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 7 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