Atlas

Form 483

D' Manolo, Inc. Form 483, 2021-10-22

FDA issued a Form 483 to D' Manolo, Inc. on 2021-10-22 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

D' Manolo, Inc. · Guaynabo, United States · Issued October 22, 2021

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.

22 Oct 2021
21 CFR 117.10

Personnel

Cited by Lizaida E Rodriguez

22 Oct 2021
21 CFR 117.35(d)

Sanitation of food-contact surfaces - Frequency

Cited by Lizaida E Rodriguez

Inspected site

DMD' Manolo, Inc.Guaynabo, United States

Inspection team

LELizaida E Rodriguez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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