Atlas

Form 483

Nucro-Technics, Inc. Form 483, 2013-09-11

FDA issued a Form 483 to Nucro-Technics, Inc. on 2013-09-11 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Nucro-Technics, Inc. · Scarborough, Canada · Issued September 11, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

11 Sep 2013
21 CFR 211.25(a)

GMP Training Frequency

Cited by Michael H Tollon, Sarah E Mcmullen

11 Sep 2013
21 CFR 211.160(b)(4)

Written calibration procedures

Cited by Michael H Tollon, Sarah E Mcmullen

Inspected site

NINucro-Technics, Inc.Scarborough, Canada

Inspection team

MHMichael H Tollon
SESarah E Mcmullen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)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