Atlas

Form 483

Preferred Pharmaceuticals, Inc. Form 483, 2009-12-30

FDA issued a Form 483 to Preferred Pharmaceuticals, Inc. on 2009-12-30 with 3 public-safe observations.

483· Form 483 issued3 observations

Preferred Pharmaceuticals, Inc. · Anaheim, United States · Issued December 30, 2009

Overview

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

Inspectional observations

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

30 Dec 2009
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Thao T Kwan, Babajide M Osunsanmi

30 Dec 2009
21 CFR 211.130(e)

Packaging line inspection before use

Cited by Thao T Kwan, Babajide M Osunsanmi

30 Dec 2009
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Thao T Kwan, Babajide M Osunsanmi

Inspected site

PPPreferred Pharmaceuticals, Inc.Anaheim, United States

Inspection team

TTThao T Kwan
BMBabajide M Osunsanmi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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