Atlas

Form 483

Bionique Testing Laboratories LLC Form 483, 2012-07-26

FDA issued a Form 483 to Bionique Testing Laboratories LLC on 2012-07-26 with 2 public-safe observations.

483· Form 483 issued2 observations

Bionique Testing Laboratories LLC · Saranac Lake, United States · Issued July 26, 2012

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.

26 Jul 2012
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Charisse K Green

26 Jul 2012
21 CFR 211.160(b)(4)

Test devices not meeting specifications

Cited by Charisse K Green

Inspected site

BTBionique Testing Laboratories LLCSaranac Lake, United States

Inspection team

CKCharisse K Green

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)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