Form 483

B & F, Inc., dba Hanmi, Inc Form 483, 2012-01-25

FDA issued a Form 483 to B & F, Inc., dba Hanmi, Inc on 2012-01-25 with 4 public-safe observations.

483· Form 483 issued4 observations

B & F, Inc., dba Hanmi, Inc · Kent, United States · Issued January 25, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

25 Jan 2012
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Jinkee M Vila Binayug, Katherine L Arnold

25 Jan 2012
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Jinkee M Vila Binayug, Katherine L Arnold

25 Jan 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Jinkee M Vila Binayug, Katherine L Arnold

25 Jan 2012
21 CFR 123.12(a)(2)

Importer verification

Cited by Jinkee M Vila Binayug, Katherine L Arnold

Inspected site

B&B & F, Inc., dba Hanmi, IncKent, United States

Inspection team

JMJinkee M Vila Binayug

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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