Form 483

Manna Organics Inc Form 483, 2018-07-06

FDA issued a Form 483 to Manna Organics Inc on 2018-07-06 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Manna Organics Inc · Newark, United States · Issued July 6, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

6 Jul 2018
21 CFR 112.147(a)

Representative samples

Cited by Crystal A Harlan, Melissa M Dauksis, Melissa M Schafer

6 Jul 2018
21 CFR 112.42(a)

Ag. water - annual inspection

Cited by Crystal A Harlan, Melissa M Dauksis, Melissa M Schafer

Inspected site

MOManna Organics IncNewark, United States

Inspection team

MMMelissa M Dauksis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 112.147(a)Cited across public-safe Form 483 observations1x
21 CFR 112.42(a)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