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Form 483

DONG GUAN KINYET METAL PRODUCTS CO., LTD. Form 483, 2019-05-30

FDA issued a Form 483 to DONG GUAN KINYET METAL PRODUCTS CO., LTD. on 2019-05-30 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

DONG GUAN KINYET METAL PRODUCTS CO., LTD. · Dongguan, China · Issued May 30, 2019

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.

30 May 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by David J Gasparovich

30 May 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by David J Gasparovich

Inspected site

DGDONG GUAN KINYET METAL PRODUCTS CO., LTD.Dongguan, China

Inspection team

DJDavid J Gasparovich

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x

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