Atlas

Form 483

Aseptic Solutions USA, LLC Form 483, 2012-02-02

FDA issued a Form 483 to Aseptic Solutions USA, LLC on 2012-02-02 with 4 public-safe observations.

483· Form 483 issued4 observations

Aseptic Solutions USA, LLC · Corona, United States · Issued February 2, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

2 Feb 2012
21 CFR 108.25(c)(1)

Registration

Cited by Jeff M Uriarte, Comyar Shoghi, Carla J Lundi

2 Feb 2012
21 CFR 108.25(c)(2)

Process filing

Cited by Jeff M Uriarte, Comyar Shoghi, Carla J Lundi

2 Feb 2012
21 CFR 110.40(a)

Precluding contaminants

Cited by Jeff M Uriarte, Comyar Shoghi, Carla J Lundi

2 Feb 2012
21 CFR 120.6(b)

Sanitation monitoring

Cited by Jeff M Uriarte, Comyar Shoghi, Carla J Lundi

Inspected site

ASAseptic Solutions USA, LLCCorona, United States

Inspection team

JMJeff M Uriarte
CSComyar Shoghi
CJCarla J Lundi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)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