Atlas

Form 483

Northern Light Eastern Maine Medical Center Form 483, 2018-12-03

FDA issued a Form 483 to Northern Light Eastern Maine Medical Center on 2018-12-03 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Northern Light Eastern Maine Medical Center · Bangor, United States · Issued December 3, 2018

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.

3 Dec 2018
21 CFR 606.151(e)

Procedures to maintain records of emergency transfusions

Cited by Elizabeth B Griffin

3 Dec 2018
21 CFR 606.171

Biological product deviation report

Cited by Elizabeth B Griffin

3 Dec 2018
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Elizabeth B Griffin

Inspected site

NLNorthern Light Eastern Maine Medical CenterBangor, United States

Inspection team

EBElizabeth B Griffin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.151(e)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 606.60(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, 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