Form 483

Rainforest Natural Products, Inc Form 483, 2025-07-23

FDA issued a Form 483 to Rainforest Natural Products, Inc on 2025-07-23 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Rainforest Natural Products, Inc · Miami, United States · Issued July 23, 2025

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

23 Jul 2025
21 CFR 111.105

Quality control - ensure quality; package, labeled, master record

Cited by Lissette Paiz

23 Jul 2025
21 CFR 111.205(a)

Master manufacturing record - prepared

Cited by Lissette Paiz

23 Jul 2025
21 CFR 111.255(a)

Batch record - every batch

Cited by Lissette Paiz

23 Jul 2025
21 CFR 111.403

Written procedures - establish; packaging & labeling

Cited by Lissette Paiz

23 Jul 2025
21 CFR 111.410(b)

Label, packaging - issuance, use

Cited by Lissette Paiz

Inspected site

RNRainforest Natural Products, IncMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.255(a)Cited across public-safe Form 483 observations1x
21 CFR 111.403Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.83(a)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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