Atlas

Form 483

Sintetica S.A. Form 483, 2014-11-21

FDA issued a Form 483 to Sintetica S.A. on 2014-11-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Sintetica S.A. · Mendrisio, Switzerland · Issued November 21, 2014

Overview

  • 2 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.

21 Nov 2014
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Chad N Thompson

21 Nov 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Chad N Thompson

Inspected site

SSSintetica S.A.Mendrisio, Switzerland

Inspection team

CNChad N Thompson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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