Form 483

Powerful Health Food Co., Ltd. Form 483, 2026-06-05

FDA issued a Form 483 to Powerful Health Food Co., Ltd. on 2026-06-05 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Powerful Health Food Co., Ltd. · Kamiminochi-Gun, Japan · Issued June 5, 2026

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

5 Jun 2026
21 CFR 111.260

Batch record - required information

Cited by Robert D Ogan

5 Jun 2026
21 CFR 111.70(b)

Specifications - components

Cited by Robert D Ogan

5 Jun 2026
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Robert D Ogan

5 Jun 2026
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by Robert D Ogan

5 Jun 2026
21 CFR 114.80(b)

Code - required elements

Cited by Robert D Ogan

Inspected site

PHPowerful Health Food Co., Ltd.Kamiminochi-Gun, Japan

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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