Atlas

Form 483

Manzana Products Co., Inc. Form 483, 2010-08-16

FDA issued a Form 483 to Manzana Products Co., Inc. on 2010-08-16 with 2 public-safe observations.

483· Form 483 issued2 observations

Manzana Products Co., Inc. · Sebastopol, United States · Issued August 16, 2010

Overview

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

16 Aug 2010
21 CFR 120.8(b)(1)

HACCP plan - food hazards not listed

Cited by Linda S Shook

16 Aug 2010
21 CFR 120.8(b)(2)

HACCP plan - critical control points not listed

Cited by Linda S Shook

Inspected site

MPManzana Products Co., Inc.Sebastopol, United States

Inspection team

LSLinda S Shook

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.8(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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