Form 483

Zesty Corporation Form 483, 2018-06-28

FDA issued a Form 483 to Zesty Corporation on 2018-06-28 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Zesty Corporation · Houston, United States · Issued June 28, 2018

Overview

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

Inspectional observations

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

28 Jun 2018
21 CFR 112.113

Handling harvested produce

Cited by Andrew J Howard, Deniza Karacic

28 Jun 2018
21 CFR 112.123(a)

Equip & tools - cleanability

Cited by Andrew J Howard, Deniza Karacic

28 Jun 2018
21 CFR 112.126(b)

Buildings - prevent contamination

Cited by Andrew J Howard, Deniza Karacic

28 Jun 2018
21 CFR 112.142(e)(1)

Treat seed with a scientifically valid method

Cited by Andrew J Howard, Deniza Karacic

28 Jun 2018
21 CFR 112.145(e)

Corrective action components of an environmental monitoring plan

Cited by Andrew J Howard, Deniza Karacic

Inspected site

ZCZesty CorporationHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 112.113Cited across public-safe Form 483 observations1x
21 CFR 112.123(a)Cited across public-safe Form 483 observations1x
21 CFR 112.126(b)Cited across public-safe Form 483 observations1x
21 CFR 112.142(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 112.145(e)Cited across public-safe Form 483 observations1x
21 CFR 112.147(a)Cited across public-safe Form 483 observations1x
21 CFR 112.147(b)Cited across public-safe Form 483 observations1x
21 CFR 112.150(b)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 observations

Every observation in full, 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