Atlas

Form 483

D' Manolo, Inc. Form 483, 2015-07-30

FDA issued a Form 483 to D' Manolo, Inc. on 2015-07-30 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

D' Manolo, Inc. · Guaynabo, United States · Issued July 30, 2015

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.

30 Jul 2015
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Adaliz Santaliz-Cruz

30 Jul 2015
21 CFR 110.35(a)

Buildings/good repair

Cited by Adaliz Santaliz-Cruz

Inspected site

DMD' Manolo, Inc.Guaynabo, United States

Inspection team

ASAdaliz Santaliz-Cruz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited 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