Form 483

Auro PR Inc. Form 483, 2015-05-22

FDA issued a Form 483 to Auro PR Inc. on 2015-05-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Auro PR Inc. · Caguas, United States · Issued May 22, 2015

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

22 May 2015
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Libia M Lugo, Laurimer Kuilan-Torres, Loreily Figueroa Agrinsoni

Inspected site

APAuro PR Inc.Caguas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full 483 report

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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