Form 483

Sun Orchard, LLC Form 483, 2018-06-15

FDA issued a Form 483 to Sun Orchard, LLC on 2018-06-15 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Sun Orchard, LLC · Haines City, United States · Issued June 15, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

15 Jun 2018
21 CFR 120.6(b)

GMP correction - timely

Cited by Robert W Calais

15 Jun 2018
21 CFR 120.6(b)

Sanitation monitoring

Cited by Robert W Calais

Inspected site

SOSun Orchard, LLCHaines City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.6(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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