Atlas

Form 483

MED&CARE (SHENZHEN) CO., LTD. Form 483, 2016-12-08

FDA issued a Form 483 to MED&CARE (SHENZHEN) CO., LTD. on 2016-12-08 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

MED&CARE (SHENZHEN) CO., LTD. · Shenzhen, China · Issued December 8, 2016

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.

8 Dec 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Camerson E Moore

8 Dec 2016
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Camerson E Moore

Inspected site

M(MED&CARE (SHENZHEN) CO., LTD.Shenzhen, China

Inspection team

CECamerson E Moore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)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