Atlas

Form 483

Aphena Pharma Solutions - Maryland, LLC Form 483, 2012-01-13

FDA issued a Form 483 to Aphena Pharma Solutions - Maryland, LLC on 2012-01-13 with 3 public-safe observations.

483· Form 483 issued3 observations

Aphena Pharma Solutions - Maryland, LLC · Easton, United States · Issued January 13, 2012

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.

13 Jan 2012
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Nebil A Oumer, Ernest Bizjak

13 Jan 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nebil A Oumer, Ernest Bizjak

13 Jan 2012
21 CFR 820.100(b)

Documentation

Cited by Nebil A Oumer, Ernest Bizjak

Inspected site

APAphena Pharma Solutions - Maryland, LLCEaston, United States

Inspection team

NANebil A Oumer
EBErnest Bizjak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)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