Atlas

Form 483

Preferred Pharmaceuticals, Inc. Form 483, 2015-10-29

FDA issued a Form 483 to Preferred Pharmaceuticals, Inc. on 2015-10-29 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Preferred Pharmaceuticals, Inc. · Anaheim, United States · Issued October 29, 2015

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

29 Oct 2015
21 CFR 211.180(e)(2)

Review of problem drugs

Cited by Doan T Nguyen, Alan P Kurtzberg

29 Oct 2015
21 CFR 211.204

Record information inclusions

Cited by Doan T Nguyen, Alan P Kurtzberg

29 Oct 2015
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Doan T Nguyen, Alan P Kurtzberg

29 Oct 2015
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Doan T Nguyen, Alan P Kurtzberg

29 Oct 2015
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Doan T Nguyen, Alan P Kurtzberg

Inspected site

PPPreferred Pharmaceuticals, Inc.Anaheim, United States

Inspection team

DTDoan T Nguyen
APAlan P Kurtzberg

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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