Atlas

FDA-Inspected Site

Jiangsu Suyun Medical Materials Co., Ltd.

3 FDA inspections are on record for Jiangsu Suyun Medical Materials Co., Ltd. in Lianyungang, China.

483· Form 483 issued

Lianyungang, China · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-10.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Apr 2026 – 10 Apr 2026Medical Devices & Rad Health483View 483 →
1 Dec 2015 – 4 Dec 2015Medical Devices & Rad Health483View 483 →
1 Dec 2014 – 9 Dec 2014Medical Devices & Rad Health483On file

Observations on record

Form 483 observations cited at this site, most recent first.

10 Apr 2026
ISO 13485:2016 Clause 7.3.6

Design and development verification not performed

Cited by Maryam Tabatabaie

10 Apr 2026
ISO 13485:2016 Clause 7.3.9

Procedures to control design and development changes not documented

Cited by Maryam Tabatabaie

10 Apr 2026
ISO 13485:2016 Clause 7.6(b)

Adjustment to measuring equipment was not performed or recorded

Cited by Maryam Tabatabaie

10 Apr 2026
ISO 13485:2016 Clause 8.4

Procedures for analysis of data not documented

Cited by Maryam Tabatabaie

4 Dec 2015
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Gregson A Joseph

Investigators

FDA investigators tied to this site in the record.

Maryam Tabatabaie1 insp.
Gregson A Joseph1 insp.
Sean T Creighton1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

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
ISO 13485:2016 Clause 7.3.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.9Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.6(b)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.4Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Jiangsu Suyun Medical Materials Co., Ltd.'s 3 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat