Form 483

Precision Science Inc Form 483, 2009-09-18

FDA issued a Form 483 to Precision Science Inc on 2009-09-18 with 9 public-safe observations.

483· Form 483 issued9 observations

Precision Science Inc · Phoenix, United States · Issued September 18, 2009

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

18 Sep 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Carla J Lundi

18 Sep 2009
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Carla J Lundi

18 Sep 2009
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Carla J Lundi

18 Sep 2009
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Carla J Lundi

18 Sep 2009
21 CFR 211.84(d)(2)

Reports of Analysis (Components)

Cited by Carla J Lundi

Inspected site

PSPrecision Science IncPhoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 226.30(c)Cited across public-safe Form 483 observations1x
21 CFR 226.58(e)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 9 observations

The source PDF and 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