Atlas

Form 483

ROVI Pharma Industrial Services S.A. Form 483, 2014-03-27

FDA issued a Form 483 to ROVI Pharma Industrial Services S.A. on 2014-03-27 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

ROVI Pharma Industrial Services S.A. · Madrid, Spain · Issued March 27, 2014

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.

27 Mar 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

27 Mar 2014
21 CFR 211.56(b)

Written sanitation procedures lacking

Cited by Noreen Muniz

27 Mar 2014
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Noreen Muniz

Inspected site

RPROVI Pharma Industrial Services S.A.Madrid, Spain

Inspection team

NMNoreen Muniz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)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