Form 483

Avara Liscate Pharmaceutical Services SPA Form 483, 2016-11-22

FDA issued a Form 483 to Avara Liscate Pharmaceutical Services SPA on 2016-11-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Avara Liscate Pharmaceutical Services SPA · Liscate, Italy · Issued November 22, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

22 Nov 2016
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by June P Page, Marie B Buen-Bigornia

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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