Atlas

Form 483

Northeast Laboratory Services, Inc. Form 483, 2016-08-17

FDA issued a Form 483 to Northeast Laboratory Services, Inc. on 2016-08-17 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Northeast Laboratory Services, Inc. · Winslow, United States · Issued August 17, 2016

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.

17 Aug 2016
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Eric C Schmitt

17 Aug 2016
21 CFR 820.25(b)

Training records

Cited by Eric C Schmitt

Inspected site

NLNortheast Laboratory Services, Inc.Winslow, United States

Inspection team

ECEric C Schmitt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)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