Atlas

Form 483

Durrset Amigos Ltd. Form 483, 2011-09-12

FDA issued a Form 483 to Durrset Amigos Ltd. on 2011-09-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Durrset Amigos Ltd. · San Antonio, United States · Issued September 12, 2011

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.

12 Sep 2011
21 CFR 110.37(e)(3)

Hand drying

Cited by Robert T Lorenz

12 Sep 2011
21 CFR 110.80

Reasonable precautions

Cited by Robert T Lorenz

Inspected site

DADurrset Amigos Ltd.San Antonio, United States

Inspection team

RTRobert T Lorenz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited 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