Form 483

Marutama Company Inc Form 483, 2010-05-21

FDA issued a Form 483 to Marutama Company Inc on 2010-05-21 with 4 public-safe observations.

483· Form 483 issued4 observations

Marutama Company Inc · Los Angeles, United States · Issued May 21, 2010

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.

21 May 2010
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Gabriel Craig

21 May 2010
21 CFR 123.6(c)(3)

Critical limits

Cited by Gabriel Craig

21 May 2010
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Gabriel Craig

21 May 2010
21 CFR 123.11(b)

Sanitation monitoring

Cited by Gabriel Craig

Inspected site

MCMarutama Company IncLos Angeles, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)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