Atlas

Form 483

KVK-Tech, Inc. Form 483, 2018-01-24

FDA issued a Form 483 to KVK-Tech, Inc. on 2018-01-24 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

KVK-Tech, Inc. · Newtown, United States · Issued January 24, 2018

Overview

  • 4 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.

24 Jan 2018
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gayle S Lawson

24 Jan 2018
21 CFR 211.63

Equipment Design, Size and Location

Cited by Gayle S Lawson

24 Jan 2018
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gayle S Lawson

24 Jan 2018
21 CFR 211.63

Equipment Design, Size and Location

Cited by Gayle S Lawson

Inspected site

KIKVK-Tech, Inc.Newtown, United States

Inspection team

GSGayle S Lawson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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