Form 483

HVF Bottling LLC Form 483, 2022-03-03

FDA issued a Form 483 to HVF Bottling LLC on 2022-03-03 with 33 public-safe observations.

483· Form 483 issuedFoods & Cosmetics33 observations

HVF Bottling LLC · Kingston, United States · Issued March 3, 2022

Overview

  • 33 public-safe observations are available for this inspection.
  • 11 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.

3 Mar 2022
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Ellen M Landis

3 Mar 2022
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Ellen M Landis

3 Mar 2022
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Ellen M Landis

3 Mar 2022
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Ellen M Landis

3 Mar 2022
21 CFR 117.165(a)(4)

Process preventive controls - Record review

Cited by Ellen M Landis

Inspected site

HBHVF Bottling LLCKingston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.165(a)(4)Cited across public-safe Form 483 observations3x
21 CFR 117.305Cited across public-safe Form 483 observations3x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.35(d)Cited across public-safe Form 483 observations3x
21 CFR 117.4Cited across public-safe Form 483 observations3x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.80(a)(5)Cited across public-safe Form 483 observations3x
21 CFR 117.80(c)Cited across public-safe Form 483 observations3x
21 CFR 117.93Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 33 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