Atlas

Form 483

Mardak Global Export, Inc Form 483, 2015-09-03

FDA issued a Form 483 to Mardak Global Export, Inc on 2015-09-03 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Mardak Global Export, Inc · Barangay Burgos Rodriguez, Philippines · Issued September 3, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

3 Sep 2015
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Dirk L Lincoln

3 Sep 2015
21 CFR 123.11(b)

Sanitation monitoring

Cited by Dirk L Lincoln

3 Sep 2015
21 CFR 123.6(c)(2)

Critical control points

Cited by Dirk L Lincoln

3 Sep 2015
21 CFR 123.6(c)(3)

Critical limits

Cited by Dirk L Lincoln

Inspected site

MGMardak Global Export, IncBarangay Burgos Rodriguez, Philippines

Inspection team

DLDirk L Lincoln

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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