Form 483

Suqian Cannery And Food Corp Ltd Form 483, 2019-07-15

FDA issued a Form 483 to Suqian Cannery And Food Corp Ltd on 2019-07-15 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Suqian Cannery And Food Corp Ltd · Suqian, China · Issued July 15, 2019

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

15 Jul 2019
21 CFR 113.100(b)

Recording device records - dated; retort number

Cited by Edith M Gonzalez, Daniel C Geffin

15 Jul 2019
21 CFR 113.40(a)(11)

Water valves, leakage

Cited by Edith M Gonzalez, Daniel C Geffin

15 Jul 2019
21 CFR 113.40(a)(8)

Still steam retorts: Bleeder not wide open during process

Cited by Edith M Gonzalez, Daniel C Geffin

15 Jul 2019
21 CFR 113.60(c)

Coding - required elements

Cited by Edith M Gonzalez, Daniel C Geffin

15 Jul 2019
21 CFR 113.89

No corrective action taken

Cited by Edith M Gonzalez, Daniel C Geffin

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.89Cited across public-safe Form 483 observations2x
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(11)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 113.60(c)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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