Atlas

Form 483

North Shore Medical Center Form 483, 2019-07-02

FDA issued a Form 483 to North Shore Medical Center on 2019-07-02 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

North Shore Medical Center · Salem, United States · Issued July 2, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

2 Jul 2019
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

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

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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