Atlas

Form 483

Ophtapharm AG Form 483, 2014-03-28

FDA issued a Form 483 to Ophtapharm AG on 2014-03-28 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Ophtapharm AG · Hettlingen, Switzerland · Issued March 28, 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.

28 Mar 2014
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Lance M De Souza

28 Mar 2014
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Lance M De Souza

28 Mar 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Lance M De Souza

Inspected site

OAOphtapharm AGHettlingen, Switzerland

Inspection team

LMLance M De Souza

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 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)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