FDA-Inspected Site

Refresqueria Otoao, Inc.

7 FDA inspections are on record for Refresqueria Otoao, Inc. in San Juan, United States.

Clean· No action indicated

San Juan, United States · Last updated July 11, 2026

Overview

  • 7 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2013-06-06.

At a glance

Inspections

7

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Jun 2013Foods & CosmeticsClean
16 Jun 2011Not recorded483On file
26 Feb 2010Not recorded483View 483 →
6 Apr 2009Not recordedClean
18 Sep 2008Not recorded483On file
13 Oct 2004Not recordedClean
10 Apr 2003Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

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

Manufacturing conditions

Cited by Patric C Klotzbuecher, Nancy Rosado

Investigators

FDA investigators tied to this site in the record.

CntrctMntr GarciaL1 insp.
Shelly A Rios Laluz1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Refresqueria Otoao, Inc.'s 3 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat