Atlas

Form 483

Piramal Critical Care Inc Form 483, 2011-08-12

FDA issued a Form 483 to Piramal Critical Care Inc on 2011-08-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Piramal Critical Care Inc · Bethlehem, United States · Issued August 12, 2011

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.

12 Aug 2011
21 CFR 211.166(a)

Written program not followed

Cited by James M Mason

12 Aug 2011
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by James M Mason

Inspected site

PCPiramal Critical Care IncBethlehem, United States

Inspection team

JMJames M Mason

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)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