Atlas

Form 483

Dr. Erik P. Pioro Form 483, 2010-07-30

FDA issued a Form 483 to Dr. Erik P. Pioro on 2010-07-30 with 2 public-safe observations.

483· Form 483 issued2 observations

Dr. Erik P. Pioro · Cleveland, United States · Issued July 30, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

30 Jul 2010
21 CFR 312.60

FD-1572, protocol compliance

Cited by Mary E Storch

30 Jul 2010
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Mary E Storch

Inspected site

DEDr. Erik P. PioroCleveland, United States

Inspection team

MEMary E Storch

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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