Atlas

Form 483

Tubilux Pharma Spa Form 483, 2016-12-09

FDA issued a Form 483 to Tubilux Pharma Spa on 2016-12-09 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Tubilux Pharma Spa · Pomezia, Italy · Issued December 9, 2016

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

9 Dec 2016
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Milva E Melendez

9 Dec 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Milva E Melendez

9 Dec 2016
21 CFR 211.165(e)

Test methods

Cited by Milva E Melendez

9 Dec 2016
21 CFR 211.68(b)

input/output verification

Cited by Milva E Melendez

Inspected site

TPTubilux Pharma SpaPomezia, Italy

Inspection team

MEMilva E Melendez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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