Form 483

Rainforest Natural Products, Inc Form 483, 2022-08-26

FDA issued a Form 483 to Rainforest Natural Products, Inc on 2022-08-26 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Rainforest Natural Products, Inc · Miami, United States · Issued August 26, 2022

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

26 Aug 2022
21 CFR 111.105

Ensure quality; package, labeled, master record

Cited by Marinee Flores-Marrero

26 Aug 2022
21 CFR 111.205(a)

Master manufacturing record - each batch

Cited by Marinee Flores-Marrero

26 Aug 2022
21 CFR 111.255(a)

Batch record - every batch

Cited by Marinee Flores-Marrero

26 Aug 2022
21 CFR 111.70(b)(1)

Specifications - component identity

Cited by Marinee Flores-Marrero

26 Aug 2022
21 CFR 111.70(d)

Specifications - labels, packaging

Cited by Marinee Flores-Marrero

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 111.70(b)(1)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 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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