Form 483

LICO Industries, LLC Form 483, 2016-08-03

FDA issued a Form 483 to LICO Industries, LLC on 2016-08-03 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

LICO Industries, LLC · Mohave Valley, United States · Issued August 3, 2016

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.

3 Aug 2016
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Chelsea N Sealey

3 Aug 2016
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Chelsea N Sealey

3 Aug 2016
21 CFR 211.56(b)

Written sanitation procedures not followed

Cited by Chelsea N Sealey

Inspected site

LILICO Industries, LLCMohave Valley, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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