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Form 483

QualTech Laboratories, Inc. Form 483, 2011-12-19

FDA issued a Form 483 to QualTech Laboratories, Inc. on 2011-12-19 with 3 public-safe observations.

483· Form 483 issued3 observations

QualTech Laboratories, Inc. · Ocean, United States · Issued December 19, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

19 Dec 2011
21 CFR 211.63

Equipment Design, Size and Location

Cited by Jose M Cayuela

19 Dec 2011
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Jose M Cayuela

19 Dec 2011
21 CFR 211.192

Written record of investigation incomplete

Cited by Jose M Cayuela

Inspected site

QLQualTech Laboratories, Inc.Ocean, United States

Inspection team

JMJose M Cayuela

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 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

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