Form 483

Northland Nuclear Medicine, LLC Form 483, 2023-07-13

FDA issued a Form 483 to Northland Nuclear Medicine, LLC on 2023-07-13 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Northland Nuclear Medicine, LLC · Bismarck, United States · Issued July 13, 2023

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.

13 Jul 2023
21 CFR 212.30(b)

Equipment procedures

Cited by Lisa L Flores

13 Jul 2023
21 CFR 212.50

Adequate controls (general)

Cited by Lisa L Flores

13 Jul 2023
21 CFR 212.50(b)(6)

Action limits on radiochemical yield

Cited by Lisa L Flores

Inspected site

NNNorthland Nuclear Medicine, LLCBismarck, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.30(b)Cited across public-safe Form 483 observations1x
21 CFR 212.50Cited across public-safe Form 483 observations1x
21 CFR 212.50(b)(6)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 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