Form 483

S & B International Corp Form 483, 2017-08-10

FDA issued a Form 483 to S & B International Corp on 2017-08-10 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

S & B International Corp · Torrance, United States · Issued August 10, 2017

Overview

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

10 Aug 2017
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Cathryn M Groehnert

10 Aug 2017
21 CFR 1.505(b)

Supplier approval - document

Cited by Cathryn M Groehnert

10 Aug 2017
21 CFR 1.506(a)(1)

Procedures - approve suppliers

Cited by Cathryn M Groehnert

10 Aug 2017
21 CFR 1.506(b)

Supplier verification procedures

Cited by Cathryn M Groehnert

10 Aug 2017
21 CFR 1.506(a)(1)

Procedures - establish, approve supplier

Cited by Cathryn M Groehnert

Inspected site

S&S & B International CorpTorrance, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 1.506(b)Cited across public-safe Form 483 observations2x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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