Atlas

Form 483

San Mar Manufacturing, Corp. Form 483, 2011-05-02

FDA issued a Form 483 to San Mar Manufacturing, Corp. on 2011-05-02 with 4 public-safe observations.

483· Form 483 issued4 observations

San Mar Manufacturing, Corp. · Catano, United States · Issued May 2, 2011

Overview

  • 4 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.

2 May 2011
21 CFR 110.20(b)(7)

Screening

Cited by Jorge L Lajara

2 May 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jorge L Lajara

2 May 2011
21 CFR 110.80

Reasonable precautions

Cited by Jorge L Lajara

2 May 2011
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Jorge L Lajara

Inspected site

SMSan Mar Manufacturing, Corp.Catano, United States

Inspection team

JLJorge L Lajara

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)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