Atlas

Form 483

North Shore Medical Center Form 483, 2014-01-15

FDA issued a Form 483 to North Shore Medical Center on 2014-01-15 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

North Shore Medical Center · Salem, United States · Issued January 15, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

15 Jan 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Alice C Silva

15 Jan 2014
21 CFR 606.100(c)

Record review prior to release

Cited by Alice C Silva

Inspected site

NSNorth Shore Medical CenterSalem, United States

Inspection team

ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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