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Form 483

Refresqueria Otoao, Inc. Form 483, 2010-02-26

FDA issued a Form 483 to Refresqueria Otoao, Inc. on 2010-02-26 with 1 public-safe observation.

483· Form 483 issued1 observation

Refresqueria Otoao, Inc. · San Juan, United States · Issued February 26, 2010

Overview

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

Inspectional observations

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

26 Feb 2010
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Patric C Klotzbuecher, Nancy Rosado

Inspected site

RORefresqueria Otoao, Inc.San Juan, United States

Inspection team

PCPatric C Klotzbuecher
NRNancy Rosado

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)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