Atlas

Form 483

Lek d.d. Form 483, 2015-06-30

FDA issued a Form 483 to Lek d.d. on 2015-06-30 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Lek d.d. · Ljubljana, Slovenia · Issued June 30, 2015

Overview

  • 3 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.

30 Jun 2015
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Christopher D Leach

30 Jun 2015
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Christopher D Leach

30 Jun 2015
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Christopher D Leach

Inspected site

LDLek d.d.Ljubljana, Slovenia

Inspection team

CDChristopher D Leach

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(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