Form 483

Spicepak, Inc. Form 483, 2017-01-04

FDA issued a Form 483 to Spicepak, Inc. on 2017-01-04 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Spicepak, Inc. · Miami, United States · Issued January 4, 2017

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

4 Jan 2017
21 CFR 110.80(a)(1)

Inspection, segregation, handling of raw materials

Cited by Lissette Paiz, Alexander B Anderson

4 Jan 2017
21 CFR 110.80(a)(1)

Inspection, segregation, handling of raw materials

Cited by Lissette Paiz, Alexander B Anderson

4 Jan 2017
21 CFR 110.80(a)(1)

Inspection, segregation, handling of raw materials

Cited by Lissette Paiz, Alexander B Anderson

4 Jan 2017
FDCA 417(d)(1)(A)

Reportable food report - submission

Cited by Lissette Paiz, Alexander B Anderson

4 Jan 2017
FDCA 417(d)(1)(A)

Reportable food report - submission

Cited by Lissette Paiz, Alexander B Anderson

Inspected site

SISpicepak, Inc.Miami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations3x
FDCA 417(d)(1)(A)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 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