Atlas

Form 483

Negril, Inc. Form 483, 2015-12-07

FDA issued a Form 483 to Negril, Inc. on 2015-12-07 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Negril, Inc. · Linthicum, United States · Issued December 7, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

7 Dec 2015
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Bobbie L Whiddon

7 Dec 2015
21 CFR 110.37(e)(2)

Hand cleaning and sanitizing preparations

Cited by Bobbie L Whiddon

Inspected site

NINegril, Inc.Linthicum, United States

Inspection team

BLBobbie L Whiddon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)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