Form 483

Lax-c Inc Form 483, 2009-09-30

FDA issued a Form 483 to Lax-c Inc on 2009-09-30 with 13 public-safe observations.

483· Form 483 issued13 observations

Lax-c Inc · Los Angeles, United States · Issued September 30, 2009

Overview

  • 13 public-safe observations are available for this inspection.
  • 13 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Sep 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Jessica L Perkins, Jonathan R Ormond, Sylvia R Dooling

30 Sep 2009
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Jessica L Perkins, Jonathan R Ormond, Sylvia R Dooling

30 Sep 2009
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Jessica L Perkins, Jonathan R Ormond, Sylvia R Dooling

30 Sep 2009
21 CFR 110.20(b)(7)

Screening

Cited by Jessica L Perkins, Jonathan R Ormond, Sylvia R Dooling

30 Sep 2009
21 CFR 110.35(d)

Failure to clean - general

Cited by Jessica L Perkins, Jonathan R Ormond, Sylvia R Dooling

Inspected site

LILax-c IncLos Angeles, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.40(e)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.12(d)Cited across public-safe Form 483 observations1x
21 CFR 123.28(c)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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