Atlas

Form 483

Pharmathen International S.A. Form 483, 2019-04-19

FDA issued a Form 483 to Pharmathen International S.A. on 2019-04-19 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Pharmathen International S.A. · Rodopi, Greece · Issued April 19, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

19 Apr 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicole E Knowlton, Sena G Dissmeyer

19 Apr 2019
21 CFR 211.68(b)

Computer control of master formula records

Cited by Nicole E Knowlton, Sena G Dissmeyer

19 Apr 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Nicole E Knowlton, Sena G Dissmeyer

19 Apr 2019
21 CFR 211.68(b)

Computer control of master formula records

Cited by Nicole E Knowlton, Sena G Dissmeyer

Inspected site

PIPharmathen International S.A.Rodopi, Greece

Inspection team

NENicole E Knowlton
SGSena G Dissmeyer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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