Atlas

Form 483

San Mar Manufacturing, Corp. Form 483, 2015-12-16

FDA issued a Form 483 to San Mar Manufacturing, Corp. on 2015-12-16 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

San Mar Manufacturing, Corp. · Catano, United States · Issued December 16, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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 Dec 2015
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jorge L Lajara

16 Dec 2015
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Jorge L Lajara

16 Dec 2015
21 CFR 110.80

Reasonable precautions

Cited by Jorge L Lajara

16 Dec 2015
21 CFR 110.80

Reasonable precautions

Cited by Jorge L Lajara

16 Dec 2015
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 110.35(c)Cited across public-safe Form 483 observations2x
21 CFR 110.80Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations2x

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