Form 483

MARUKAI HAWAII CO LTD Form 483, 2021-07-21

FDA issued a Form 483 to MARUKAI HAWAII CO LTD on 2021-07-21 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

MARUKAI HAWAII CO LTD · Honolulu, United States · Issued July 21, 2021

Overview

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

Inspectional observations

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

21 Jul 2021
21 CFR 1.502(a)

Develop FSVP

Cited by Jason T Tuuao

Inspected site

MHMARUKAI HAWAII CO LTDHonolulu, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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