Form 483

Donggang Hongxing Food Co., Ltd. Form 483, 2019-05-23

FDA issued a Form 483 to Donggang Hongxing Food Co., Ltd. on 2019-05-23 with 18 public-safe observations.

483· Form 483 issuedFoods & Cosmetics18 observations

Donggang Hongxing Food Co., Ltd. · Donggang, China · Issued May 23, 2019

Overview

  • 18 public-safe observations are available for this inspection.
  • 6 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.

23 May 2019
21 CFR 123.11(b)

Sanitation monitoring

Cited by Clara E Santiago

23 May 2019
21 CFR 123.11(c)

Sanitation Records

Cited by Clara E Santiago

23 May 2019
21 CFR 123.6(b)

HACCP plan implementation

Cited by Clara E Santiago

23 May 2019
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Clara E Santiago

23 May 2019
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Clara E Santiago

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations3x
21 CFR 123.11(c)Cited across public-safe Form 483 observations3x
21 CFR 123.6(b)Cited across public-safe Form 483 observations3x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations3x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations3x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 18 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