Atlas

Form 483

Jiangsu Suyun Medical Materials Co., Ltd. Form 483, 2015-12-04

FDA issued a Form 483 to Jiangsu Suyun Medical Materials Co., Ltd. on 2015-12-04 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Jiangsu Suyun Medical Materials Co., Ltd. · Lianyungang, China · Issued December 4, 2015

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

4 Dec 2015
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Gregson A Joseph

4 Dec 2015
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Gregson A Joseph

4 Dec 2015
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Gregson A Joseph

Inspected site

JSJiangsu Suyun Medical Materials Co., Ltd.Lianyungang, China

Inspection team

GAGregson A Joseph

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, 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